Ignite Creation Date:
2024-05-06 @ 1:19 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01779908
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2013-01-24
Brief Title:
Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Role of Vitamin D in the Prevention and Treatment of Diseases Associated With Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIDIR
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 25OHD 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
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 25OHD 55 nM men and women aged 25 years and over with a BMI 40 kgm2 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 17 mmolL or treated dyslipidemia 2 prediabetes or untreated type 2 diabetes HbA1c 56 or fasting glucose 56 mmolL or glucose 2h post OGTT 78 mmolL 3 first degree relative with type 2 diabetes 4 history of gestational diabetes Participants will be randomized according to sex BMI 30 kgm2 vs 30 kgm2 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 minglucose 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 25OHD with changes in blood markers associated with insulin sensitivity hs-CRP inflammatory cytokines IL-6 and TNF-alpha adiponectin leptin total and undercarboxylated osteocalcin
Part 2 Mechanistic studies comparing before and after vitamin D3 supplementation changes in serum 25OHD 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B12-12-1095 | None | None | None |