Type2 Diabetes, Vitamin D Deficiency
Conditions
Keywords
vitamin D, type 2 diabetes, inflammation
Brief summary
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.
Detailed description
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.
Interventions
DIETARY_SUPPLEMENTcholecalciferol (Euro-Pharm International, Canada)
The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
DIETARY_SUPPLEMENTPlacebo tablet
The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
Sponsors
Université d'Auvergne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.
Intervention model description
In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months
Eligibility
Sex/Gender
ALL
Age
60 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Subjects deficient in vitamin D * Subjects having type 2 diabetes * Non-obese subjects
Exclusion criteria
* Subjects having hyperparathyroidism * Subjects suffering from hepatic disease / kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline TNF-alpha at 6 months | baseline and after 6 months of intervention | TNF-alpha |
| Change from Baseline fasting blood glucose (FBG) at 6 months | baseline and after 6 months of intervention | FASTING BLOOD GLUCOSE |
| Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months | baseline and after 6 months of intervention | Homeostatic Model Assessment of Insulin Resistance |
| Change from Baseline C-reactive protein (CRP) at 6 months | baseline and after 6 months of intervention | C-reactive protein |
| Change from Baseline Interleukin-6 (IL-6) at 6 months | baseline and after 6 months of intervention | Interleukin-6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline weight at 6 months | baseline and after 6 months of intervention | weight change |
| Change from Baseline Body Mass Index (BMI) at 6 months | baseline and after 6 months of intervention | Body mass index |
| Change from Baseline waist circumference at 6 months | baseline and after 6 months of intervention | Waist circumference change |
| Change from Baseline Percentage of fat at 6 months | baseline and after 6 months of intervention | Percentage of fat |
| Change from Baseline Parathyroid hormone (PTH) at 6 months | baseline and after 6 months of intervention | Parathyroid hormone |
Countries
Lebanon
Outcome results
None listed