Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Karl-Heinz Wagner, PhD

Annemarie Grindel

Helmuth Brath, MD

The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients

Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

Incidence of Chromosomal Damage in Type 2 Diabetes Patients

In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c\<7.5%) and a high (HbA1c\>7.5%) glycemic group

The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease.

University of Vienna

Director Research Platform Active Ageing

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

Sung Kyu Hong, M.D, Ph.D

Jae-kyung Oh, B.S.

The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).

The investigators will prospectively collect the relevant data including preoperative HbA1c in 264 patients of PCa patients undergoing RP. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.

* This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with prostate cancer (PCa) undergoing radical prostatectomy (RP).
* Particularly, the investigators check the variables, including age at surgery, body mass index, comorbidities, preoperative PSA levels, prostate volume measured by TRUS, preoperative HbA1c levels, biopsy Gleason score, positive biopsy cores, percent positive cores, clinical TMN staging, final pathological results (TMN stage, Gleason score, extraprostatic extension, seminal vesicle invasion, surgical margin positivity, postoperative biochemical recurrence (BCR), local recurrence, and distant metastasis during follow-up periods.
* The study protocol is same with routine follow-up schedule of the patients with PCa treated with RP. Typically, the investigators check the patients at 1, 3, 6, 9, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
* Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.

Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

Prospective Cohort Study for the Impact of Preoperative Glycemic Control Status Measured by HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer

BCR was defined as either two consecutive increases in serum PSA (\>0.2 ng/mL) or the administration of adjuvant therapy during the postoperative follow-up period

Gleason scores of prostate cancer specimen described in final pathological report

Seoul National University Hospital

Associate professor

Symptoms and General Pathology

Immune System Diseases

Syndrome

Hypersensitivity

Polycystic Ovary Syndrome

Insulin Resistance

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Hyperinsulinism

Micronutrients

Hypoglycemic Agents

Bone Density Conservation Agents

Vitamins

Insulin

Insulin, Globin Zinc

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Vitamin D3 (cholecalciferol) supplementation (50,000 IU/week for 8 weeks) followed by 1000 IU/day for 16 weeks

Placebo pills will be given 1 per week for 8 weeks followed by 1 per day for 16 weeks

Vitamin D3 pills

Placebo pills similar in appearance and shape but without vitamin D

Placebo pills

Mohammed-Salleh M Ardawi, PhD, FRCPath

Abdulrahim A Rouzi, FRCPC

Veronica B Orbacedo, BSc

Ramia Al-sobhi, BSc

Ahmed Y Ali, MD

Ghazi Y Refai, MD

Mohammed H Qari, FRCPA

Heba S Kary, MD

The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.

Polycystic ovary syndrome (PCOS) is a common complex and heterogenous endocrine disorder. It affects ≤10% of women of reproductive age, with approximately 16%-80% of the affected women being obese. Polycystic ovary syndrome frequently is associated with insulin resistance (IR) accompanied by compensatory hyperinsulinemia, and IR is aggravated by the interaction between obesity and the syndrome. Moreover, the contribution of body mass and/or body fat distribution to IR of PCOS remains controversial. In addition, women with PCOS with IR are at an increased risk of developing diabetes, hypertension, dyslipidemia and atherosclerosis. Preliminary data on the local women with PCOS showed high prevalence of vitamin D deficiency (serum 25(OH)D \< 50 nmol/L). Recent studies showed that vitamin D deficiency is linked to IR, type 2 diabetes mellitus, obesity, inflammation and cardio vascular disease. Several studies have demonstrated that serum 25(OH)D levels were negatively correlated with body mass index (BMI), body fat, and IR. These conditions are common among women with PCOS. Accordingly, it is anticipated that vitamin D deficiency and/or insufficiency may contribute to the endocrine and metabolic disarrangements among women with PCOS. Such adverse effects may further contribute to the risk of further long term complications among women with PCOS.

Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome

Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome

Other endpoints were changes in inflammatory markers (hs-CRP)

Other endpoints were changes in lipid profile (total cholesterol, HDL-c, LDL-c, and triglycerides)

Other endpoints were changes in liver function tests \[albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase(ALP)\]; renal function tests (cystatine C, uric acid, urea) and parathyroid hormone (PTH)

Other endpoints were changes in HbA1c, fasting plasma glucose and fasting plasma insulin

Other endpoints were changes in serum 25-hydroxyvitamin D

Other endpoints were changes in (follicle-stimulating hormone, luteinizing hormone, prolactin, thyroid-stimulating hormone, free thyroxine, total testosterone, dehydroepiandrosterone (DHEA), DHEA sulfate, delta 4-androstenedione and sex-hormone binding globulin).

The primary endpoint was an improvement in insulin resistance parameters \[Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) \] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.

Secondary endpoints were changes in parameter of insulin sensitivity\[ quantitative insulin sensitivity check index (QUICKI)\], among vitamin D supplemented group vs placebo group from baseline and at the end of the trial

King Abdulaziz University

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)	NCT02231736	Type 2 Diabetes Cancer		30 Years -	University of Vienna
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer	NCT02436122	Prostate Neopla... Pathology		20 Years - 80 Years	Seoul National University Hospital
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer	NCT02436122	Prostate Neopla... Pathology		20 Years - 80 Years	Seoul National University Hospital
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)	NCT02231736	Type 2 Diabetes Cancer		30 Years -	University of Vienna
Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer	NCT02436122	Prostate Neopla... Pathology		20 Years - 80 Years	Seoul National University Hospital
Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome	NCT02164552	Polycystic Ovar...	Vitamin D3 pill... Placebo pills	20 Years - 45 Years	King Abdulaziz University

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