Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
This study is currently recruiting participants.
Verified May 2011 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Albert Einstein College of Medicine of Yeshiva University
Information provided by:
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01354964
First received: May 12, 2011
Last updated: May 16, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insulin Resistance |
Drug: Vitamin D |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 25 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin D
Vitamin D
|
Drug: Vitamin D
Weekly oral vitamin D drops, weight-based calculated dosage, taken on the same day each week for 4 months.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age 21-60 years old
- Serum 25(OH)D<20ng/ml
- Insulin Resistant based on HOMA-IR score of >3
- Able and willing to provide informed consent
- BMI 27-35
Exclusion Criteria:
- FPG greater than or equal to 126 mg/dl or 2-hour-OGTT plasma glucose greater than or equal to 200 mg/dl
- Diagnosed diabetes mellitus
- HIV/AIDS
- History of any cancer
- Sarcoidosis
- Alcohol or substance abuse
- Cushing's syndrome
- Primary hyperparathyroidism
- Nephrolithiasis
- Pregnancy or breastfeeding
- Regular visits to a tanning salon
- Hypercalcemia or hypocalcemia
- Untreated or uncontrolled hypertension
- Any chronic illness requiring medication, other than arthritis, hypertension and hyperlipidemia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354964
Contacts
| Contact: Stephanie M Lawrence, BS | 718-430-2903 | stephanie.lawrence@einstein.yu.edu |
Locations
| 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 stephanie.lawrence@einstein.yu.edu | |
| Principal Investigator: Preeti Kishore, MD | |
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
| Principal Investigator: | Preeti Kishore, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
No publications provided
| Responsible Party: | Preeti Kishore, Albert Einstein College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01354964 History of Changes |
| Other Study ID Numbers: | 2008-225 |
| Study First Received: | May 12, 2011 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
|
Glucose Metabolism Disorders Insulin Resistance Endocrine System Vitamin D |
Additional relevant MeSH terms:
|
Inflammation Insulin Resistance Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Vitamin D Ergocalciferols |
Vitamins Insulin Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 19, 2013