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Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation

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ClinicalTrials.gov Identifier: NCT01354964
Recruitment Status : Completed
First Posted : May 17, 2011
Results First Posted : March 9, 2020
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine

Brief Summary:
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 on specific cells and processes in fat tissue.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: Vitamin D Drug: Placebo Phase 2

Detailed Description:

Over the last several years, studies have shown that low vitamin D levels may increase risk of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels <20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue.

Investigators will study participants with a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Adipose tissue inflammation will be measured using the following inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
Actual Study Start Date : March 13, 2009
Actual Primary Completion Date : June 3, 2015
Actual Study Completion Date : September 3, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D
Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months.
Drug: Vitamin D
Other Name: Vitamin D3 (cholecalciferol)

Placebo Comparator: Placebo
Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months.
Drug: Placebo



Primary Outcome Measures :
  1. Percent Change in Hepatic Insulin Sensitivity [ Time Frame: 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months) ]
    Endogenous glucose production (EGP) was assessed at each study visit to evaluate hepatic insulin sensitivity. Percent change between the EGP at baseline and second visit (after treatment for up to 3 months with Vitamin D to reach a target level of ≥30 ng/ml), and baseline and third visits (after treatment for up to 6 months with Vitamin D in order to reach a target level of ≥50 ng/ml) will be calculated.


Secondary Outcome Measures :
  1. Percent Change in Peripheral Glucose Uptake [ Time Frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) ]
    The rate of glucose uptake to determine peripheral insulin sensitivity was measured using the rate of disappearance (Rd) of glucose at each study visit. Percent change between the Rd at baseline and second visit (after treatment with Vitamin D for up to 3 months to target level of ≥30 ng/ml), and baseline and third visits (after treatment with Vitamin D for up to 6 months to target level of ≥50 ng/ml) will be calculated.

  2. Evaluated Expression of Pro-inflammatory Gene TNF-α [ Time Frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) ]
    Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. TNF-α gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.

  3. Evaluated Expression of Pro-inflammatory Gene IL-6 [ Time Frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) ]
    Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. IL-6 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.

  4. Evaluated Expression of Pro-inflammatory Gene iNOS [ Time Frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) ]
    Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. iNOS gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.

  5. Evaluated Expression of Pro-inflammatory Gene PAI-1 [ Time Frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) ]
    Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. PAI-1 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Serum 25(OH)D<20ng/ml
  • Insulin Resistant based on HOMA-IR score of >3
  • Able and willing to provide informed consent
  • BMI 20-35

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354964


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Meredith A Hawkins, M.D., M.S. Albert Einstein College of Medicine
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Responsible Party: Meredith Hawkins, Professor of Medicine (Endocrinology), Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01354964    
Other Study ID Numbers: 2008-225
5K23RR023335-02 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2011    Key Record Dates
Results First Posted: March 9, 2020
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meredith Hawkins, Albert Einstein College of Medicine:
Glucose Metabolism Disorders
Insulin Resistance
Endocrine System
Vitamin D
Additional relevant MeSH terms:
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Insulin Resistance
Inflammation
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents