Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
Recruitment status was Recruiting
The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation and/or on specific cells and processes in fat tissue, and on function of skeletal muscle and joints.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation|
- Hepatic insulin sensitivity [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]We will examine endogenous glucose production to assess hepatic insulin sensitivity.
- Peripheral insulin sensitivity [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]We will examine the rate of glucose uptake to determine peripheral inslin sensitivity.
- Adipose tissue inflammatory markers/Cytokines in plasma [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]Inflammatory markers-PAI-1, IL-6, TNF-a, iNOS
- Neuropsychological Testing [ Time Frame: 4 months ] [ Designated as safety issue: No ]We will conduct neuropsychological testing to assess cognitive function.
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D
Drug: Vitamin D
Weekly oral vitamin D drops, weight-based calculated dosage, taken on the same day each week for 4 months.
Over the last several years, studies have shown that low vitamin D levels may increase risk of development of Type 2 Diabetes. The investigators will administer vitamin D3 (Cholecalciferol) to nondiabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels < 20 ng/ml) to increase the level of vitamin D initially to 30-50ng/ml and then to higher normal range of 51-75 ng/ml. The investigators will study its effects on insulin action, adipose tissue inflammation, and musculoskeletal function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354964
|Contact: Stephanie M Lawrence, BSfirstname.lastname@example.org|
|United States, New York|
|Albert Einstein College of Medicine of Yeshiva University||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Stephanie Lawrence, BS 718-430-2903 email@example.com|
|Principal Investigator: Preeti Kishore, MD|
|Principal Investigator:||Preeti Kishore, MD||Albert Einstein College of Medicine of Yeshiva University|