Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Heart and Blood Diseases

Syndrome

Obesity

Polycystic Ovary Syndrome

Prehypertension

Prediabetic State

Metabolic Syndrome

Glucose Intolerance

Insulin Resistance

Hyperinsulinism

Metabolic Diseases

Glucose Metabolism Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Vascular Diseases

Subjects assigned to heat therapy underwent 30 1-hour hot tub sessions over 8-10 weeks (3-4 per week). The hot tub was set to 40.5 Celsius, and core temperature and heart rate were monitored throughout each session.Subjects were instructed to not make any other dietary or lifestyle changes.Cardiovascular and metabolic health assessments were made Pre (0 heat sessions), mid (after 14-16 heat sessions, \~4-5 weeks), and post (after all 30 heat sessions; \~8-10 weeks).

Subjects were monitored at matched timepoints (start of study, 4-5 weeks, and 8-10 weeks) but not exposed to any intervention. Subjects were instructed to not make any dietary or lifestyle changes.

Heat therapy

Traditional medical treatments are often based on research done exclusively in males, and recent research efforts in the physiology community have highlighted critical sex differences in disease presentation and progression. For example, the relative risk of fatal heart disease is 50% greater in obese, diabetic women as compared to their male counterparts, and women appear to respond differently to lifestyle interventions such as exercise compared with men. Chronic passive heat exposure (hot tub use) provides alternative or supplemental therapeutic potential for improving cardiovascular and metabolic health in obese women. In addition, passive heat exposure may offer specific cellular protection from stresses like a lack of blood flow (ischemia), which is the primary cause of fatal coronary heart disease. This study is investigating the possible cardiovascular and metabolic health benefits of chronic passive heat exposure, and whether regular hot tub use (3-4 days per week for 8-10 weeks) may reduce obese womens' cardiometabolic risk. The investigators are examining cardiovascular health through blood pressure, blood vessel stiffness, sympathetic ('fight or flight') activity, and responsiveness to stresses like increased or decreased blood flow. The investigators are also examining metabolic health through an oral glucose tolerance test and a subcutaneous fat biopsy. The goal of this research is to develop a therapy targeted toward the specific health needs and complications of obese women, in an effort to improve cardiovascular and metabolic health and provide therapeutic alternatives in this high-risk population.

Subjects were matched for age and BMI, then assigned to either a heat therapy intervention or time control (no intervention, just outcomes assessment at matched timepoints).

It was not possible to blind the subject or PI to treatment group, but all measures that were collected were analyzed offline by a blinded investigator.

Heat Therapy and Cardiometabolic Health in Obese Women

serum measurement of high-sensitivity C-reactive protein, global inflammatory marker

Resting supine blood pressure, measured in triplicate with median recorded

glucose and insulin responses to a 75-g, 2-hr oral glucose tolerance test after a 12+hr fast

recording of sympathetic nerve traffic during supine rest, quantified as burst count per minute

intimal thickness of common carotid artery assessed using doppler ultrasonography

intimal thickness of superficial femoral artery assessed using doppler ultrasonography

arterial compliance of common carotid artery measured using ultrasonography

arterial compliance of superficial femoral artery measured using ultrasonography

flow-mediated dilation of brachial artery, expressed as % change in diameter. A measure of endothelial function.

flow-mediated dilation of brachial artery, expressed as % change in diameter, following 20 minute ischemia-20 minute reperfusion. A measure of vascular tolerance to ischemia-reperfusion stress.

Adipose tissue sample analyzed for insulin signaling, markers of inflammation, and heat shock protein expression

American Heart Association

University of Oregon

Kenneth & Kenda Singer Endowed Professor

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Hypoglycemic Agents

All Drugs and Chemicals

Reproductive Control Agents

Anti-Obesity Agents

Antineoplastic Agents

Gastrointestinal Agents

Metformin

Liraglutide

Glucagon-Like Peptide-1 Receptor Agonists

Glucagon-Like Peptide 1

Contraceptive Agents

Exenatide

Contraceptives, Oral

Cyproterone Acetate

Cyproterone

Glucagon

Incretins

Hormones

Hormone Antagonists

Contraceptive Agents, Female

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-GLP-1 Receptor Agonist

Metformin-Oral Contraceptive(OC)

Min long, MD

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Concentration of LH was measured in mIU/ml.

Weight and height will be combined to report BMI in kg/m\^2.

Alanine transaminase was measured in IU/L.

Systolic blood pressure was measured in mmHg.

Changes in testosterone levels were measured

Xinqiao Hospital of Chongqing

Deputy Chief Physician, Associated professor

Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.

Metformin-GLP-1 Receptor Agonist: metformin oral with exenatide/liraglutide subcutaneous injection.

Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.

Metformin-Oral Contraceptive(OC): metformin with Diane 35 oral intake.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

China

Region of Enrollment

weight

Limitations of this trial include a relatively small sample size and single-center design.

Min Long, MD

Assessment of Reproductive Functions

Basic Vital Signs

Assessment of Liver Function

Assessment of Blood Pressure

Assessment of Reproductive Function

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Diabetes Mellitus

Lung Diseases

Neurodegenerative Diseases

Licia Iacoviello, MD, PhD

Cardiovascular disease and malignancies account for more than 70% of all causes of mortality and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle, that often defines the line between health and sickness. So far studies aiming at identifying risk factors have mainly come from Northern Europe and the USA. It was to understand this balance between genetics and environmental determinants better, and to tailor appropriate preventive strategies for Italian and other Southern European populations, that the Moli-sani study was launched, transforming a small Italian region into a large scientific laboratory: the "Molise lab".

Each participant received a thorough medical check-up at no cost to either him/her or the national health service, resulting in thousands of hours of free public health care. With a completely computerized system, Moli-sani is a "paperless" study, in which researchers and participants communicate using recently developed technologies such as mobile phone text messages (SMS). The biological data bank (the "MoliBank") is one of the largest in Europe. Paying particular attention towards innovation and new technologies, the Moli-sani study has placed itself at the cutting edge of a new paradigm crossing research and prevention

The cohort of the Moli-sani study has recruited 24,325 persons, aged \>35 years, resident in the Molise region.The latter covers an area of 4,438 Km2, including 136 towns. Participants are recruited from city-hall registries by a multistage sampling. Firstly townships were sampled in three major areas of Molise region, starting from the main cities (Campobasso, Termoli, Isernia) by cluster sampling, then, within each township, participants are selected by simple random sampling, using electronically generated numbers.Exclusion criteria are pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form. All subjects identified are sent a letter inviting them to participate in the project, followed a few days later by a phone call. The recruitment started in the area of Campobasso, then it moved to the areas of Termoli.

Blood samples obtained from participants who had fasted overnight and had refrained from smoking for at least 6 h and stored in liquid nitrogen in the Biological bank of the Moli-sani study.

The Moli-sani Study

An Epidemiological Study of Risk Factors for Cardiovascular Disease and Tumors in an Adult Population of the Molise Region

sumbmission of a research proposal form to be approved by the Moli-sani scientific committee and signature of a research agreement.

Primary fatal and nonfatal incident cases of CHD (unstable angina, myocardial infarction, coronary revascularization and sudden death for unspecified cardiac event) and cerebrovascular disease that occurred in the cohort during follow-up

Primary fatal and nonfatal incident cases of cancer that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

Primary fatal and nonfatal incident cases of heart failure that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

Primary fatal and nonfatal incident cases of atrial fibrillation that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry

Primary incident cases of diabetes that occurred in the cohort during follow-up, assessed by cross-linkage with hospital discharge record and regional death registry or pharmacological prescription registry. Diabetes onset is defined as blood glucose ≥126 mg/dl or by use of specific pharmacological treatment

Neuromed IRCCS

MD, PhD

Behaviors and Mental Disorders

Hypertension

Depression

Depressive Disorder

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

Subjects receiving hands-on cooking and nutrition education classes

Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)

The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.

Treatment

Dominique Monlezun, MD, PhD, MPH

Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact of hands-on cooking and nutrition education on patient outcomes, with those classes taught by medical students and other future and current medical professionals who have first been trained in those classes on how to integrate diet and lifestyle counseling of patients with their respective scopes of clinical practice. CHOP is the primary research study of the world's first known medical school based teaching kitchen, The Goldring Center for Culinary Medicine at Tulane University School of Medicine. Medical trainees and professionals are followed in this study long-term to understand how the classes impact their competencies in patient counseling, attitudes about the counseling, and their own diets. Patients who consent to being randomized to these classes compared to standard of care are studied within the nested Bayesian adaptive randomized trial to understand how the classes impact their health outcomes, clinical and food costs, and the costs of health systems caring for these patient populations. CHOP is designed as a pragmatic population health trial to hopefully improve healthcare effectiveness, equity, and cost by establishing an evidence-based, scalable, sustainable model of healthcare intervention targeting the social determinants of health, while complementing the pharmacological and/or surgical management of patients.

Cooking for Health Optimization With Patients

Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)

Re-presenting to the hospital for similar presenting diagnosis (for patients)

Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)

Direct and indirect (for health systems caring for the patients in the trial)

Grocery and restaurant costs (for patients)

Tulane University

Subjects receiving hands-on cooking and nutrition education classes

Treatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.

Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees/providers) or medical care (for patients)

Control

Race (NIH/OMB)

United States

Principal Investigator

High or Medium (Versus Low) Mediterranean Diet Adherence

Hospital Readmissions

Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event

Competencies

Healthcare Costs

Food Costs

Testicular Neoplasms

Endocrine Gland Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Male Urogenital Diseases

Testicular Diseases

Cisplatin

Ninian Lang, MBChB PhD

Chemotherapy drugs improve cancer survival but increase the risk of cardiovascular disease (CVD). VEGF inhibitors (VEGFI) cause severe hypertension, while cisplatin appears pro-thrombotic. Hence while cancer survival may improve, this is at the risk of potentially severe CVD and associated morbidity. Mechanisms underlying the cardiovascular toxicities of VEGFI and cisplatin are unknown, but effects on vascular function may be important.

The INTELLECT study will phenotype the endothelial effects of VEGFI and cisplatin using a variety of methods.

There remains an unmet need to identify a preventive treatment for patients with testicular cancer treated with platinum based chemotherapy to diminish the risk of subsequent cardiovascular events. A future randomised trial of statin therapy in these patients is under consideration and results from this study will inform its design.

The information gained from this pilot study will guide the development of interventional pharmacological studies that are directed towards the most appropriate pathophysiological processes, at the most appropriate time and in the most appropriate patient groups treated with platinum based chemotherapy for testicular cancer.

Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer

expressed as ml per 100 ml of forearm volume per minute

University of Glasgow

NHS Greater Glasgow and Clyde

Skin and Connective Tissue Diseases

Breast Neoplasms

Cardiomyopathies

Breast Diseases

Skin Diseases

Heart Diseases

Echocardiography

Nhat M. Giang, M.D

Nguyen H. Hai, Ph.D

Hai H. Nguyen, Ph.D

The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks

Chemotherapy induced cardiomyopathy is a serious adverse effect of anticancer treatments with poor long-term prognosis. In addition to the cumulative dose of anthracycline and trastuzumab, cardiovascular risks have been proven to be the "second hit" when dealing with chemotherapy related cardiomyopathy in breast cancer patients. Speckle-tracking echocardiography have had robust evidence in diagnosis the early stage of left ventricular dysfunction in various types of cancer treated by cardiotoxicity drugs. However, data is still lacking regarding the role of speckle-tracking echocardiography in breast cancer patients with cardiovascular risk

2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors

The Role of 2D Speckle-tracking Echocardiography in Diagnosis Chemotherapy-induced Cardiomyopathy in Breast Cancer Patients With High Cardiovascular Risk Factors

Gia Dinh People Hospital

Diabetes Mellitus, Type 2

Anxiety Disorders

A physical activity referral scheme co-developed by multidisciplinary stakeholders to incorporate behaviour change support and ensure pragmatic relevance and feasibility.

Comparative, usual care exercise referral scheme.

Lifestyle advice leaflet only (provided to participants in all arms during baseline assessments).

An 18-week physical activity referral scheme co-developed by a local multidisciplinary stakeholder group. Behaviour change support underpinned by Self-Determination Theory (Ryan \& Deci, 2000) will be provided by an exercise referral practitioner at weeks 1,4,8,12 and 18 to facilitate increased physical activity levels. Patients will be supported to develop a tailored programme of physical activity that may involve use of the fitness centre facilities (e.g. swimming, group classes, gymnasium use), participation in community-based initiatives, and changes to habitual physical activity. Focus on promoting patient autonomy and tailoring activities to patient's preferences and needs. Subsidised access to fitness centre facilities for first 12 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Heat Therapy and Cardiometabolic Health in Obese Women	NCT03644524	Obesity Polycystic Ovar... Prehypertension PreDiabetes Cardiovascular ... Metabolic Syndr...	Heat therapy	18 Years - 40 Years	University of Oregon
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS	NCT03151005	Polycystic Ovar... Overweight Obesity	Metformin-GLP-1... Metformin-Oral ...	18 Years - 50 Years	Xinqiao Hospital of Chongqing
The Moli-sani Study	NCT03242109	Cardiovascular ... Cardiovascular ... Cancer Neurodegenerati... Diabetes Pulmonary Disea...		35 Years -	Neuromed IRCCS
Cooking for Health Optimization With Patients	NCT03443635	Cardiovascular ... Cardiovascular ... Nutrition Disor... Diabetes Hypertension Cancer Depression Obesity Physical Activi...	Treatment	7 Years - 115 Years	Tulane University
Heat Therapy and Cardiometabolic Health in Obese Women	NCT03644524	Obesity Polycystic Ovar... Prehypertension PreDiabetes Cardiovascular ... Metabolic Syndr...	Heat therapy	18 Years - 40 Years	University of Oregon
Intermediate and Long Term Vascular Effects of Cisplatin in Patients With Testicular Cancer	NCT03557164	Testicular Canc... Cardiovascular ... Cardiovascular ...		18 Years - 50 Years	NHS Greater Glasgow and Clyde
Cooking for Health Optimization With Patients	NCT03443635	Cardiovascular ... Cardiovascular ... Nutrition Disor... Diabetes Hypertension Cancer Depression Obesity Physical Activi...	Treatment	7 Years - 115 Years	Tulane University
The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS	NCT03151005	Polycystic Ovar... Overweight Obesity	Metformin-GLP-1... Metformin-Oral ...	18 Years - 50 Years	Xinqiao Hospital of Chongqing
2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors	NCT04547465	Cardiomyopathy ... Breast Cancer Cardiovascular ...	Echocardiograph...	18 Years -	Gia Dinh People Hospital
Evaluation of a Physical Activity Referral Scheme	NCT03490747	Cardiovascular ... Diabetes Mellit... Anxiety Depression Musculoskeletal... Cardiovascular ... Cancer Obesity Metabolic Syndr... Physical Activi...	Physical activi... Usual care exer...	18 Years -	Liverpool John Moores University

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