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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

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.


Condition or disease Intervention/treatment Phase
Vitamin D-deficient Insulin-resistant Dietary Supplement: Vitamin D Other: Placebo Not Applicable

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].

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
Study Start Date : January 2013
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2020

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 supplementation
5000 IU of vitamin D3 for 6 months
Dietary Supplement: Vitamin D
Placebo Comparator: Placebo
Placebo pill for 6 months
Other: Placebo



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change in insulin secretion indice between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    area under the curve for C-peptide

  4. Change in insulin secretion indice between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    HOMA2-B

  5. Change in insulin secretion indice between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    insulinogenic index

  6. Change in B-cell function between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Disposition index

  7. Change in metabolic markers between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    HbA1c

  8. Change in metabolic markers between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Fasting glucose

  9. Change in metabolic markers between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    2h glucose post-OGTT

  10. Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Weight

  11. Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    BMI

  12. Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    waist circumference

  13. Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    hip circumference

  14. Change in anthropometry between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    fat mass by bioimpedance analysis

  15. Change in blood pressure between placebo and vitamin D groups [ Time Frame: 0 and 6 months ]
    Systolic and diastolic blood pressure



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01779908


Locations
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Canada, Quebec
CHU de Québec, Laval University Research Center
Quebec city, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Diabetes Association
Laval University
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: Claudia Gagnon, Dr. CHU de Québec Research Center
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Responsible Party: Claudia Gagnon, MD, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01779908    
Other Study ID Numbers: CDA grant no OG-3-12-3681-CG
B12-12-1095
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Keywords provided by Claudia Gagnon, CHU de Quebec-Universite Laval:
Vitamin D supplementation
Insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents