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Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance (VIDIR)

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ClinicalTrials.gov Identifier: NCT01779908
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : July 24, 2020
Sponsor:
Collaborators:
Canadian Diabetes Association
Laval University
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Claudia Gagnon, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date July 24, 2020
Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2020)
  • Change in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    M-value
  • Change in peripheral insulin sensitivity assessed by the euglycemic-hyperinsulinemic clamp between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    M/I ratio
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Change from baseline in peripheral insulin sensitivity at 6 months [ Time Frame: 0 and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2020)
  • Change in insulin sensitivity indice assessed by fasting- and oral glucose tolerance test between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    HOMA2%S
  • Change in insulin sensitivity indice assessed by fasting- and oral glucose tolerance test between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Matsuda index
  • Change in insulin secretion indice between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    area under the curve for C-peptide
  • Change in insulin secretion indice between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    HOMA2-B
  • Change in insulin secretion indice between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    insulinogenic index
  • Change in B-cell function between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Disposition index
  • Change in metabolic markers between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    HbA1c
  • Change in metabolic markers between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Fasting glucose
  • Change in metabolic markers between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    2h glucose post-OGTT
  • Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Weight
  • Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    BMI
  • Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    waist circumference
  • Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    hip circumference
  • Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    fat mass by bioimpedance analysis
  • Change in blood pressure between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Systolic and diastolic blood pressure
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Change from baseline in glucose homeostasis at 6 months [ Time Frame: 0 and 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 29, 2013)
Changes from baseline in cytokines/adipokines at 6 months [ Time Frame: 0 and 6 months ]
 
Descriptive Information
Brief Title  ICMJE Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
Official Title  ICMJE Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
Brief Summary

Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient men and women aged 25 years and over. Participants will have abdominal obesity and at least one factor associated with insulin resistance. Participants will be randomized by sex, BMI and age. The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism, the lipid profile, blood pressure and anthropometric measurements. Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, changes in serum 25(OH)D will be correlated with changes in blood markers associated with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin].

This research project intends to test 2 major hypotheses: (1) that vitamin D deficiency plays a causal role in the pathogenesis of insulin resistance in humans; and (2) that vitamin D increases insulin sensitivity.

Detailed Description

Part 1: Prospective, randomized and placebo-controlled 6-month trial of vitamin D supplementation in 130 Caucasian and vitamin D-deficient [serum 25(OH)D ≤55 nM] men and women aged 25 years and over with a BMI ≤40 kg/m2. Participants will have abdominal obesity (increased waist circumference of at least 102 cm for men and 88 cm for women) and at least one factor associated with insulin resistance, namely: (1) serum triglyceride levels of at least 1.7 mmol/L or treated dyslipidemia; (2) prediabetes or untreated type 2 diabetes (HbA1c >=5.6% or fasting glucose >=5.6 mmol/L or glucose 2h post OGTT >=7.8 mmol/L); (3) first degree relative with type 2 diabetes; (4) history of gestational diabetes. Participants will be randomized according to sex, BMI (<30 kg/m2 vs. 30 kg/m2 and over) and age (< or >=50 years old). The primary aim is to compare the effect of daily vitamin D3 (cholecalciferol, 5000 IU) vs. placebo for 6 mo on insulin sensitivity (M-value by the gold standard method, the euglycemic hyperinsulinemic clamp). Secondary aims are to evaluate the effects of vitamin D3 vs. placebo on other indices of glucose metabolism (fasting glucose, 2-h plasma glucose post OGTT, HbA1c, insulin sensitivity index (HOMA-IS using fasting glucose and insulin), insulin secretion index (HOMA-B using fasting glucose and C-peptide), insulinogenic index [(C-peptide at 30 min post OGTT - C-peptide at 0 min)/(glucose at 30 min post OGTT - glucose at 0 min)] and disposition index (insulinogenic index x M-value)), the lipid profile, blood pressure and anthropometric measurements (weight, waist and hip circumference, bioimpedance analysis). Questionnaires on physical activity and sunlight exposure, and a food frequency questionnaire will be administered at 0 and 6 mo to adjust for confounding factors. At 0 and 6 mo, biochemical markers associated with insulin sensitivity will be measured (point 2).

Part 2: Mechanistic studies comparing, before and after vitamin D3 supplementation, changes in serum 25(OH)D with changes in blood markers associated with insulin sensitivity [hs-CRP, inflammatory cytokines (IL-6 and TNF-alpha), adiponectin, leptin, total and undercarboxylated osteocalcin].

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Vitamin D-deficient
  • Insulin-resistant
Intervention  ICMJE
  • Dietary Supplement: Vitamin D
  • Other: Placebo
Study Arms  ICMJE
  • Experimental: Vitamin D supplementation
    5000 IU of vitamin D3 for 6 months
    Intervention: Dietary Supplement: Vitamin D
  • Placebo Comparator: Placebo
    Placebo pill for 6 months
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2020)
96
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2013)
144
Actual Study Completion Date  ICMJE June 2020
Actual Primary Completion Date June 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Caucasian men and women
  • ≥25 yrs
  • vitamin D deficiency [serum 25(OH)D concentration ≤55 nM]
  • Abdominal obesity (waist circumference >=102 cm for men and >=88 cm for women) AND at least one factor associated with insulin resistance: (1) fasting serum triglycerides >=1.7 mmol/L or treated dyslipidemia; (2) prediabetes or untreated type 2 diabetes (HbA1c >=5.6% or fasting glucose >=5.6 mmol/L or 2h glucose post OGTT >=7.8 mmol/L); (3) first degree relative with type 2 diabetes; (4) history of gestational diabetes.

Exclusion Criteria:

  • Type 2 diabetes under drug therapy
  • HbA1c >7%
  • BMI >40 kg/m2
  • pregnancy or breast-feeding;
  • medication influencing vitamin D or glucose metabolism in the last 3 mo
  • regular consumption of supplements containing >400 IU/d of vitamin D3 over the last 2 mo;
  • renal insufficiency (creatinine clearance <60 ml/min);
  • cirrhosis,
  • intestinal malabsorption (bypass surgery, celiac disease, etc);
  • osteoporosis;
  • history of nephrolithiasis;
  • hypercalcemia (>2.6 mM);
  • hypercalciuria (>0.6 fasting urine Ca/creatinine ratio);
  • >5% change in weight in the last 3 mo;
  • diseases affecting glucose metabolism (e.g. hyperthyroidism);
  • pacemaker (for bioimpedance only);
  • inability to provide informed consent and complete questionnaires due to physical or mental problems.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779908
Other Study ID Numbers  ICMJE CDA grant no OG-3-12-3681-CG
B12-12-1095
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Claudia Gagnon, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE
  • Canadian Diabetes Association
  • Laval University
  • Fonds de la Recherche en Santé du Québec
Investigators  ICMJE
Principal Investigator: Claudia Gagnon, Dr. CHU de Québec Research Center
PRS Account CHU de Quebec-Universite Laval
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP