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:
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
  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 April 14, 2014