Aging Clinical Trial
Official title:
Randomized Control Trial of Vitamin D Supplementation on Surrogate Markers of Ageing, Association/Interactions With Selected Ageing-related Genes, Glycemic and Metabolic Markers in North Indian Individuals With the Prediabetes
NCT number | NCT04025489 |
Other study ID # | DFI |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | March 30, 2024 |
Prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of important for prevention of diabetes. It is not clear if apparent accelerated aging in Indian population associated with heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dys-metabolic state etc. could, besides lifestyle factors, be related to vitamin D deficiency, or ageing-related genes, or interaction between the two. This study is based on the assumption that the supplementation of vitamin d could lead to reversal to normal glucose regulation and may slow aging process in individuals with pre-diabetes.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 30, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility | Inclusion and Exclusion Criteria of Cross Sectional and Prospective Study: Cross-sectional Study: Inclusion Criteria: Individuals with prediabetes, aged 20-60 years. Exclusion Criteria: 1. Received Vitamin D or calcium supplementation in the previous six months. 2. On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism and on any medication that activate steroid and xenobiotic receptors, and drugs used in transplantation. 3. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc. 4. Known case of diabetes mellitus, HIV infection and other endocrine disorders. Prospective Intervention Study: Design: Randomized open labeled placebo-controlled trial. Inclusion Criteria: 1. Pre-diabetes: 1. Fasting blood glucose =100mg/dl and <125.99mg/dl, or 2. 2-h plasma glucose =140mg/dl and <200mg/dl (after ingestion of 75 g anhydrous oral glucose), and 2. Baseline blood level of 25 hydroxy vitamin D <30ng/dl. 3. Aged 20-60 years Exclusion Criteria: 1. Received Vitamin D and/or calcium supplementation in the previous six months. 2. On any medication within last one month which could potentially influence insulin secretion, insulin sensitivity, vitamin D or calcium metabolism (e.g. metformin, thiazolidinediones, steroids etc) and on any medication that activate steroid and xenobiotic receptor and drugs used in transplantation (e.g. steroids, calcitonin etc.) 3. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy, nephrotic syndrome, malabsorption etc. 4. Known case of HIV infection. 5. Primary or tertiary hyperparathyroidism, granulomatous disorders (e.g. sarcoidosis) and any lymphomas. 6. Known case of diabetes mellitus. |
Country | Name | City | State |
---|---|---|---|
India | Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology | Delhi |
Lead Sponsor | Collaborator |
---|---|
Diabetes Foundation, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigation of gene polymorphism and other markers in 500 subjects | single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] Asian Indians with prediabetes. | 1 year | |
Secondary | Effect of vitamin d supplementation on raging and other metabolic measures. | Vitamin D supplementation could Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes.
Increase/preserve leucocyte telomerase length and activity, thus having positive effects on ageing. Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes. |
2 year |
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