Diabetes, Insulin Resistance, Low-intensity Chronic Inflammation
Conditions
Keywords
vitamin D, diabetes, C-reactive protein, insulin resistance
Brief summary
Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus. The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM). The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.
Detailed description
Methods. Randomized, double blind, placebo-controlled clinical trial. We selected 104 postmenopausal women, ages 45 to 65, with uncomplicated T2DM and BMI ≥25. Women with history of kidney or liver disease, BMI\>40, autoimmune disease or cancer were not included in the study. Participants were randomly assigned to receive either a capsule containing 4,000 IU of vitamin D3 (cholecalciferol, n=52) or placebo (n=52), once a day during 6 months. Outcome variables were serum CRP, measured with a high-sensitivity assay (nephelometry), and HOMA-IR. Serum vitamin D (25-OH-D) was measured by HPLC. Outcome variables were measured at baseline, and 3 and 6 months thereafter. All participants received diet and physical activity counseling, and visited the clinic for medical check-up once a month. Baseline Results. Mean age was 56.8 ± 5.1 y. Baseline BMI was 30.7 ± 3.9. Median CRP concentration was 5.0 mg/L (Interquartile range: 1.0, 8.5). HOMA index at baseline was 7.13 ± 3.8. Serum 25-OH-D concentration at baseline was 54.5 ± 15.7 nmol/L (\ 22 ng/mL). Almost 94% of patients had baseline serum 25-OH-D levels \<80 nmol/L, and 25% were below 40 nmol/L. No one had levels \<20 nmol/L. There were no statistical differences on important variables by treatment group at the onset of study.
Interventions
4,000 IU per day during 6 months. Capsule form.
no active principles given.
Sponsors
Study design
Eligibility
Inclusion criteria
* Type 2 diabetes mellitus w/ \< 10 yrs of diagnosis * Postmenopausal * Overweight or obesity (BMI \>=25) * Treated with metformin
Exclusion criteria
* BMI \>=40 * Liver or kidney disease * Other important chronic disease: i.e. cancer, autoimmune. * Receiving insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-. | 3 and 6 months |
| Insulin resistance, measured by HOMA-IR index | 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Serum 25-OH-vitamin D3 levels | 3 and 6 months |
Countries
Mexico