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Your journey
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More info
You can access this
clinical trial
if you have
Obesity or Insulin Resistance
and you are
between 35 and 75
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

Type 2 diabetes is a major public health problem in India with an estimated a prevalence of approximately 4% and 12% in rural and urban areas respectively. Accumulating evidence suggests that serum cholecalciferol levels may be inversely related to the prevalence of diabetes, insulin resistance and metabolic syndrome. The trials available on the effect of Vitamin D supplementation on insulin/glucose metabolism have been conducted using small sample sizes in different subgroups document variable results (significant decrease in HbA1c concentration with insulin concentration in hemodialysis patients; insulin levels lower with oral Vitamin D in gestational diabetes; no effect of Vitamin D on serum insulin levels in post menopausal women). A double blind randomized controlled trial conducted at our institute using 3,60,000 IU of cholecalciferol over 6 weeks documented improvement in OGIS index of insulin sensitivity. We therefore, plan to study the long term effect of vitamin D supplementation on peripheral insulin sensitivity.

Provided treatments

  • Drug: Cholecalciferol
  • Drug: placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01052181. The sponsor of the trial is Dr Jitender Nagpal and it is looking for 300 volunteers for the current phase.
Official trial title:
A Double Blind Randomized Control Trial to Study the Effect of Long Term Vitamin D Supplementation on Peripheral Insulin Sensitivity in Apparently Healthy Middle Aged Centrally Obese Adults