Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on September 18, 2014