Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Diabetes Mellitus, Type 2

Kidney Diseases

Stroke

Diabetes Mellitus

Syndrome

Hypertension

Chronic Disease

Obesity

Metabolic Syndrome

Death

Sarcopenia

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Disease Attributes

Insulin Resistance

Hyperinsulinism

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Chronic Graft Versus Host Disease

Yuming Chen

Changyi Wang, PhD

Objective: The Nanshan Elderly Cohort Study (NECS) aims to investigate the nutritional, as well as other environmental and genetic factors of chronic diseases, such as cardio-metabolic diseases.

Study design: NECS is a community-based prospective cohort study. Participants: About 10000-20000 apparently healthy residents, living in Nanshan， Shenzhen (South China) for \>5 years, aged ≥ 65 years, will be recruited between 2018 and 2019.

Visits and Data Collection: Participants will be followed up approximately every 3 years by invited to the Community Healthcare Service Centre. At each survey, face-to-face interviews, anthropometric measurements, ultrasonography examination, electrocardiogram test and specimen collection will be conducted.

Key variables:

1. Face-to-face interviews: Structured questionnaires will be used to collect the participants' socio-demographic characteristics, lifestyles, habitual dietary intake, physical activity, history of chronic diseases, use of supplements and medications, family history, psychological health and cognitive function.
2. Physical examinations: Anthropometric measurements, blood pressure tests, handgrip strength, and usual gait speed.
3. Ultrasonography examinations: Ultrasonography examination will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
4. Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
5. Specimen collections: Overnight fasting blood sample, early morning first-void urine sample and faeces samples will be collected and stored at -80°C till tests.
6. Laboratory tests:

   1. Blood tests: Metabolic syndrome-related indices; nutritional indices; inflammatory markers; sexual hormones; genetic markers.
   2. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
   3. Fecal test: Gut microbiota and related metabolites.
7. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
8. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Objective: The Nanshan Elderly Cohort Study (NECS) aims to investigate the nutritional, as well as other environmental and genetic factors of chronic diseases, such as hypertension, type 2 diabetes mellitus, cardiovascular diseases, stroke, obesity, metabolic syndrome, chronic kidney disease, cancer and sarcopenia.

Study design: NECS is a community-based prospective cohort study. Participants: Healthy residents who had lived in Nanshan， Shenzhen (South China) for \>5 years, aged ≥ 65 years are eligible. Participants would be excluded if they are confirmed to have serious chronic diseases, such as cardiovascular disease, liver or renal failure, or cancer. About 10000-20000 apparently healthy residents will be recruited between 2018 and 2019.

Visits and Data Collection: Participants will be followed up approximately every 3 years by invited to the Community Healthcare Service Centre. At each survey, face-to-face interviews, anthropometric measurements, ultrasonography examinations, electrocardiogram test and specimen collection will be conducted.

Key variables:

1. Face-to-face interviews: Structured questionnaires will be used to collect the participants' socio-demographic characteristics (e.g., age, sex and household income, education level), lifestyles (smoking, passive smoking, alcohol and tea drinking), habitual dietary intake (a 62-item quantitative food frequency questionnaire), physical activity, history of chronic diseases, use of supplements and medications, family history, psychological health (Self-Rating Anxiety Scale, SAS), social support and participation, cognitive function (Mini-Mental State Examinations, MMSE);
2. Physical examinations: Anthropometric measurements (weight, height, waist, hip and neck circumference, etc.), blood pressure tests, handgrip strength, and usual gait speed.
3. Ultrasonography examinations: Ultrasonography examination of the carotid artery and upper abdominal organs (e.g., liver and kidney) will be performed to determine carotid artery intima-media thickness and plaque, fatty liver.
4. Electrocardiogram test: Electrocardiogram test is to obtain information about the structure and function of the heart.
5. Specimen collections: Overnight fasting blood sample will be collected and separated into serum, plasma, red blood cell and leukocyte within two hours. Early morning first-void urine sample and faeces samples will be collected. All specimens will separated and stored at -80°C till tests.
6. Laboratory tests:

   1. Metabolic syndrome-related indices: Fasting serum lipid profile (e.g., cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol), diabetes-related indices (e.g., glucose, glycated hemoglobin, fructosamine and insulin), uric acid and creatinine;
   2. Nutritional indices: Serum concentrations of carotenoids, erythrocyte fatty acids, serum minerals, folate, betaine, choline, TMAO, and vitamin D, etc.
   3. Inflammatory markers (e.g., hsCRP, RBP4，IL-6, TNF-a)
   4. Sexual hormones (e.g., testosterone, SHBG)
   5. Genetic markers
   6. Urinary tests: Flavonoids and flavones, minerals, creatinine and renal function related markers.
   7. Fecal test: Gut microbiota and related metabolites.
7. Morbidity and mortality: Relevant data will be also retrieved via local multiple Health information systems.
8. Others: Many other laboratory tests or instrument tests will be developed depended on needs and resources in future.

Statistical analysis: Cox proportional hazards models or logistic regression models will be used to estimate the risk of exposures on categorical outcomes. Path analysis also will be used to assess the potential mediating effects in the causal pathway between exposures and outcomes.

Overnight fasting blood sample, early morning first-void urine sample and faeces samples will be collected at baseline and follow-up。

Nanshan Elderly Cohort Study

Nanshan Elderly Cohort Study：a Community-based Prospective Cohort Study in Nanshan， Shenzhen Residents

The investigators will also track for occurrence of diabetes mellitus by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will track for occurrence of cardiovascular diseases by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will track for occurrence of stroke by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will track for occurrence of cognitive disorder by follow-up surveys and annual record linkage to the population-based disease or death registry collected by the Shenzhen Center for Disease Control and Prevention, and Health Insurance Bureau. All cases will be verified by medical record reviews.

The investigators will measure metabolic syndrome-related indices at each visit (per every 3 years), the investigators can analysis the incidence of metabolic syndrome.

The investigators will measure fasting lipid profile (e.g., cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol) at each visit, and analyse the change of these indices.

The investigators will measure the handgrip strength, which will be used to diagnose sarcopenia according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for handgrip strength (\<26 kg for men and \<18 kg for women).

The investigators will measure the usual gait speed., which will also be used to diagnose sarcopenia according to definition recommended by Asian Working Group for Sarcopenia (AWGS): cutoff values for usual gait speed (\<0.8 m/s).

Shenzhen Nanshan Center for Chronic Disease Control

Sun Yat-sen University

Professor

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

COVID-19

Anemia, Sickle Cell

Communicable Diseases

Obesity, Morbid

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Sickle Cell Anemia

All Drugs and Chemicals

Immunosuppressive Agents

Patients over the age of 18 hospitalized for SARS-CoV-2 up to end of June 2020 in the San Gerardo Hospital and other centers will be included.

Patients are followed until discharge from hospital or death.

Maria Grazia Valsecchi, Prof.

llaria Capua, Prof.

Retrospective multi-center cohort study. Consecutive patients hospitalized for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) up to October 2020 will be included. Patients are followed until discharge from hospital or death.

Background

A virus causing clusters of severe pneumonia was first detected in the city of Wuhan, China, in December 2019.

This pathogen was designated as SARS-CoV-2. Although of probable zoonotic origin, human-to-human transmission has rapidly fuelled the spread of SARS-CoV-2 infection globally.

On February 20th, the first case of locally acquired SARS-CoV-2 infection was diagnosed in Northern Italy in a critically ill, hospitalized young man with no travel history to known areas of viral circulation or link to a probable or confirmed coronavirus infectious disease 2019 (COVID-19) case. Prior to this date, only three cases of COVID-19 had been reported in Central Italy, all with a travel history to Wuhan. Following this unexpected finding, case counts, and death tolls has increased rapidly in the country with a total of 192,994 confirmed cases and 25,969 deaths as of 24 April 2020.

Study rationale

Multiple variables have been described as possible risk factors for SARS-CoV-2 susceptibility, severity and prognosis, among which age, sex and comorbidities play an important role.

Centers for Disease Control and Prevention (CDC) listed the underlying medical conditions that have shown to increase the risk of severe illness from SARS-CoV-2. While some comorbidities, such as serious heart conditions and chronic kidney disease have a consistent and strong evidence as bad prognostic factors in SARS-CoV-2 infection, others as HIV have a limited evidence and heterogeneous results.

Further, despite it is well-known that the burden of co-existing diseases may be additive or even multiplicative, the effect of specific disease cluster on COVID-19 adverse outcomes has never been evaluated. Finally, the proposed models and risk scores currently available to predict disease severity and mortality are poorly reported and at high risk of bias, raising concern that their predictions could be unreliable when applied in daily practice. A reliable risk/prognostic score developed by a multidimensional and cross-validated approach will pave the way for future research on frail sectors of the population and on the use of health system resources. At the clinical level, a prognostic score will allow to predict severity and mortality risk in patients requiring hospitalization and to stratify patients according to clinical severity helping clinicians in their therapeutic decision-making.

Objectives

The primary objective of the study is to evaluate the role of patient's comorbidities on clinical outcome in patients hospitalized for SARS-CoV-2. The investigators will confirm risk predictors already known and provide evidence for the uncertain ones. The investigators will also develop a prognostic score able to predict negative clinical outcomes (primarily short-term mortality), that will be useful to stratify patients at hospital admission according to their different risk profiles, and therefore to "tailor" the individuals' level of care.

A secondary objective could be that to extend this approach at the susceptible population level, especially the elders, to stratify according to the higher risk of being infected by SARS-CoV-2, hospitalized and to have a dismal outcome (not developed here but related to a possible amendment).

Sample size

The investigators expect the total number of patients with complete data to be approximately 2500, based on the expected recruitment of each center.

Analysis Plan

Data will be summarized by counts and percentage and quartiles for categorical and continuous variables, respectively. Multi-state models will be used to describe patient's hospital mortality and discharge. In-hospital mortality will be estimate accounting for discharge as competing event. Kaplan-Meier estimator will be used to estimate mortality up to 3-months from admission. The role of patient's comorbidities on clinical outcome will be evaluated by the Cox model adjusting for relevant confounders. A clinically-based prognostic score will be developed including comorbidities and other risk factors. The score will be constructed by a multidimensional approach and Lasso approach will be used to select relevant risk factors. The Area Under the Receiving Operating Characteristics curve (AUC) and Brier score will be used to evaluate model performance and the final score will be cross-validated. A sensitivity analysis will be performed using a training and test validation approach. The use of regression trees for a practical definition of risk subgroups and latent variable models will also be considered.

Multiple imputation will be performed if missing would exceed 10%.

Data collection

Consecutive patients hospitalized for SARS-CoV-2 up to October 2020 will be included. Given the difficulty in systematically obtaining written informed consent and given the great public interest of the project, the research will be conducted in the context of the authorizations guaranteed by Article 89 of the General Data Protection Regulation (GDPR) EU Regulation 2016/679, which guarantees processing for purposes of public interest, for scientific or historical research or for statistical purposes of health data.

Comorbidities and Risk Score in COVID-19 Patients

Comorbidities and Risk Score for Severity and Outcome in Patients With Infection by SARS-CoV-2.

Description of the hospital mortality caused by the COVID19 disease

Description of the mortality patients up to 3 months from admission

Description of the complications occurred during the hospital course

Description of the possible correlation between the admission of ICU and in-hospital mortality of the patients

University of Milano Bicocca

Hypoglycemic Agents

Insulin

Insulin, Globin Zinc

Bagels made from high-resistant starch flour (provides 24g resistant starch per day)

In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.

Resistant Starch

Alison M Duncan, Ph.D., R.D.

The purpose of this study is to determine if consumption of bagels made with resistant starch for 8 weeks can improve markers of type 2 diabetes, colon cancer and satiety in adults.

Using a randomized, double-blind crossover study design, we will determine the effect of consuming bagels made with resistant starch daily for 8-weeks can reduce the risk of type 2 diabetes and colon cancer in an adults who are at an increased risk for type 2 diabetes. Additionally, we will compare the satiating effect of these bagels to that of a standard bagel.

The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer

Human Clinical Trial to Investigate the Effects of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer in Adults at Risk for Type 2 Diabetes

Questionnaires will be used to measure the participants' responses to the aroma, appearance, taste and texture of the study bagels.

Questionnaires about bagel tolerance, including subjective ratings of tolerance and any adverse events will be completed every 2 weeks throughout both treatment periods (adverse events will be recorded as often as needed).

Body weight will be measures at every study visit.

Total-cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides will be measured from fasted blood samples on days 1 and 57 of both treatment periods.

Participants will complete 3-day food records a total of 3 times throughout the study to provide information about their background nutrient intake and dietary habits.

Blood glucose will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.

Circulating insulin will be measured in the fasting state and postprandially (during a 3-hour oral glucose tolerance test) on the first and last study days of both treatment periods.

HbA1c (glycated haemoglobin) will be measured from fasting blood drawn on days 1 and 57 of both treatment periods.

Data will be used from 3-hour oral glucose tolerance tests performed on days 1 and 57 of both treatment periods.

After study bagel consumption as part of a standard breakfast, questionnaires will be used to quantify subjective measures of satiety, and weighted food records will be used to objectively measure food intake for the rest of the day.

Ontario Ministry of Agriculture, Food and Rural Affairs

Maple Leaf Foods, Canada Bread

University of Guelph

Alison Duncan, Ph.D., R.D., Professor

Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Mersina

To determine the safety and efficacy of an Ayurvedic formulation, Mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.

Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs

Jyoti Clinical and Pathological Laboratory

Jayavant M Jain

Prior to hospital discharge, patients receive CGM application and education on how to apply the CGM, and how to use the sensor and its associated smart phone app. Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days.

Receive basic diabetes mellitus education

Educational Intervention

Medical Device Usage and Evaluation

Survey Administration

Kathleen M Dungan, MD, MPH

This clinical trial studies the effect of a continuous glucose monitor application in improving outcomes in patients with poorly controlled type 2 diabetes and active cancer. Patient satisfaction with type 2 diabetes management influences medication-taking behavior as well as health outcomes. Adding continuous glucose monitor application to diabetes treatment plan after hospital discharge plan may improve patient satisfaction and reduce diabetes distress.

PRIMARY OBJECTIVE:

I. Evaluate if addition of continuous glucose monitor (CGM) to diabetes treatment plan following inpatient hospitalization is associated with improved patient satisfaction with DM management in patients with cancer and poorly controlled type 2 diabetes mellitus.

SECONDARY OBJECTIVES:

I. Evaluate feasibility of CGM initiation upon hospital discharge. II. Evaluate effect of CGM on recognition of post-hospitalization hypoglycemia. III. Evaluate patient reported outcome of CGM incorporation into patient diabetes care burden.

IV. Evaluate effect of CGM on depression score before and after CGM use.

OUTLINE:

Prior to hospital discharge, patients receive CGM application and education on how to apply the CGM, and how to use the sensor and its associated smart phone application (app). Patients also receive basic diabetes mellitus education. After hospital discharge, patients use CGM for up to 28 days.

Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer

Effect of Continuous Glucose Monitor Application Following Hospital Discharge of Poorly Controlled Patients With Type 2 Diabetes and Active Malignancy

Descriptive statistics will summarize the sample characteristics and distribution of each variable. Change over time in continuous variables will be reported as paired t-test or nonparametric test as appropriate.

Descriptive statistics will summarize the sample characteristics and distribution of each variable.

Will report the safety of continuous glucose monitor application and use. Descriptive statistics will summarize the sample characteristics and distribution of each variable.

Ohio State University Comprehensive Cancer Center

Principal Investigator

Hypogonadism

Gonadal Disorders

Anticoagulants

Reproductive Control Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Citrate

Placebo

Capsules 12.5 mg or 25 mg 1x daily for 3 months

Androxal

Glenn Cunningham, MD

The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism

A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.

Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus

A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nanshan Elderly Cohort Study	NCT03569735	Hypertension Type 2 Diabetes... Cardiovascular ... Stroke Obesity Metabolic Syndr... Sarcopenia Chronic Kidney ... Cancer Death		65 Years -	Sun Yat-sen University
Comorbidities and Risk Score in COVID-19 Patients	NCT04670094	Covid19		18 Years -	University of Milano Bicocca
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer	NCT02129946	Type 2 Diabetes...	Resistant Starc...	40 Years -	University of Guelph
Evaluation of Safety and Efficacy of Mersina, an Ayurvedic Formulation: A Double Blind, Placebo Controlled Study in Type 2 Diabetic Patients With Secondary Failure to Oral Drugs	NCT00940251	Antihyperglycem...	Mersina	30 Years - 60 Years	Jyoti Clinical and Pathological Laboratory
Continuous Glucose Monitor Application After Hospital Discharge for the Improvement of Outcomes in Patients With Poorly Controlled Type 2 Diabetes and Active Cancer	NCT04938869	Hematopoietic a... Malignant Solid... Type 2 Diabetes...	Educational Int... Medical Device ... Survey Administ...	-	Ohio State University Comprehensive Cancer Center
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus	NCT01191320	Type 2 Diabetes... Secondary Hypog...	Placebo Androxal	20 Years - 80 Years	Repros Therapeutics Inc.
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer	NCT02129946	Type 2 Diabetes...	Resistant Starc...	40 Years -	University of Guelph
Nanshan Elderly Cohort Study	NCT03569735	Hypertension Type 2 Diabetes... Cardiovascular ... Stroke Obesity Metabolic Syndr... Sarcopenia Chronic Kidney ... Cancer Death		65 Years -	Sun Yat-sen University
The Effect of Resistant Starch Bagels on Risk Factors of Type 2 Diabetes and Colorectal Cancer	NCT02129946	Type 2 Diabetes...	Resistant Starc...	40 Years -	University of Guelph

Spots Global Cancer Trial Database for type 2 diabetes mellitus