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Vitamin D Supplementation on Surrogate Markers of Ageing, Ageing Genes, Glycemic and Metabolic Markers in North India

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ClinicalTrials.gov Identifier: NCT04025489
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Anoop Misra, Diabetes Foundation, India

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Supplementation PreDiabetes Aging Dietary Supplement: Randomized control trial of vitamin D supplementation Not Applicable

Detailed Description:

Asian Indians develop metabolic syndrome and diabetes earlier than in most population. In other words, Asian Indians have all the risk factors which may predispose to accelerated ageing; insulin resistance, dysglycemia, subclinical inflammation, and vasculopathy.

Vitamin D deficiency is widespread in both urban and rural populations of India. It is possible that vitamin D may also act on pathway related to aging which also are common to chronic diseases like diabetes. In this respect the surrogate markers of ageing (leukocyte telomerase length and telomerase activity) could be affected if vitamin D deficiency occurs. While some studies have shown relationship between vitamin D supplementation and leukocyte telomerase length in other populations, such study has not been systematically performed in Asian Indians. In this context, it is also not clear if some proposed genes of ageing may have some influence of development of prediabetes or diabetes and may interact with vitamin D. One of the candidate gene MSTN, according to our previous study, showed close correlation with excess body fat and decrease muscle mass, body composition characteristics conducive to development of diabetes. Additionally, deficiency of vitamin D could be linked to insulin resistance, prediabetes, though these issues have been debated. Some studies suggest that vitamin D supplementation may improve insulin sensitivity in Asian Indians. A research focusing on relationship of vitamin D supplementation with pro-ageing metabolic factors (glycemia, insulin resistance etc,), ageing related genes and surrogate markers of ageing is needed.

This study has two components; cross-sectional and prospective. Cross-sectional study will be of 2 years duration where 500 subjects from urban area of Delhi will be screened randomly for the vitamin D deficiency and its determinants including duration of sun exposure. The population will be representative of different socio-economic strata of the society. In this, vitamin D levels, leukocyte telomerase length and telomerase activity in peripheral blood leukocytes, telomerase activity and single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] in prediabetes Asian Indians.

Second part consists of open-label randomized placebo-controlled prospective trial, in which the investigators would be enrolling 200 prediabetic subjects with vitamin D deficiency. These subjects will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one year intervention. As mentioned above, genes related to ageing will be evaluated. Appropriate statistical methods will be used to see effects of intervention with Vitamin D on metabolic state (particularly insulin resistance and glycemia) and leukocyte telomerase length and telomerase activity. Effects of polymorphisms of pro-ageing genes will be assessed


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D and Placebo
Doses of cholecalciferol (commercial name, Calcirol) 60,000IU (sachets, dissolved in half glass milk) once per week for eight weeks to intervention group and placebo (Lactose Granules) to the placebo group according to the random numbers generated by the computer.
Dietary Supplement: Randomized control trial of vitamin D supplementation
This open-label randomized placebo-controlled prospective trial will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one-year intervention. As mentioned above, genes related to ageing will be evaluated. Effects on polymorphisms of pro-ageing genes will be assessed.




Primary Outcome Measures :
  1. Investigation of gene polymorphism and other markers in 500 subjects [ Time Frame: 1 year ]
    single nucleotide polymorphisms [ACTN3, VDR, FOXO3A, SIRT1 and MSTN] Asian Indians with prediabetes.


Secondary Outcome Measures :
  1. Effect of vitamin d supplementation on raging and other metabolic measures. [ Time Frame: 2 year ]

    Vitamin D supplementation could Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes.

    1. Increase/preserve leucocyte telomerase length and activity, thus having positive effects on ageing.
    2. Improve insulin action and glucose physiology, leading to lowering of blood glucose levels in persons with prediabetes.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025489


Contacts
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Contact: Anoop Misra, MD 01141759672 anoopmisra@gmail.com
Contact: Surya P Bhatt, PhD 919810085720 suryabhat@gmail.com

Locations
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India
Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology
Delhi, India
Sponsors and Collaborators
Diabetes Foundation, India

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Responsible Party: Dr Anoop Misra, Presidant, Diabetes Foundation, India
ClinicalTrials.gov Identifier: NCT04025489     History of Changes
Other Study ID Numbers: DFI
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will be conducted at the outpatient department of National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI) and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Anoop Misra, Diabetes Foundation, India:
Pre-diabetes
Type 2 Diabetes
Genes
Supplementation
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents