Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar

Supreme Council Of Health, Qatar

Status: Unknown

Conditions: Insulin Resistance

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02098980

INDDIQAT Trial

Vitamin D and Diabetes (Other Grant/Funding Number)

Details and patient eligibility

About

There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will decrease insulin resistance and the associated metabolic indices linked to the later development of T2DM.

Full description

Epidemiologically, there is an association between elevated T2DM risk and low serum levels of vitamin D and suggest that it may protect against the diseases through the improvement of insulin sensitivity as well as secretion and reducing chronic inflammation. Although some of these effects were shown in clinical studies, no study permitted the inference that vitamin D can reduce blood glucose and attenuate inflammation. Post-prandial glucose is the most sensitive to alterations in insulin sensitivity. Therefore, it is rational to examine whether vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM and to elucidate the mechanism by which this occurs, i.e. via improved insulin sensitivity or improved insulin secretion, or both. Furthermore, identifying a distinct proteomics-based signature that can be used to distinguish responders to supplementation from non-responders is critical to define the bases for inter-individual variation in response and the effect of vitamin D on the prevention of T2DM. Identification of this proteomics-based signature will enable us to tailor alternative preventive measures to adjust the vitamin D dose to non-responders, leading to more effective and precise intervention protocols.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or non-pregnant, non-lactating females, aged 18-75

• volunteered to participate by signing the consent form

• BMI ˂ 40kg/ m2

• serum 25(OH) vitamin D3 (25(OH)D) concentration ˂75nmol/L

• fasting serum glucose <7.0 mmol/L

• HOMA insulin resistance index ≥1.3

• presence of any ONE OR MORE of the following risk factors for type 2 diabetes:

  • high BMI (>23)
  • high waist circumference according to IDF ethnic specific values for non- Caucasian (females >80cm; males >90cm)
  • family history of diabetes in first-degree relative (parent or sibling)
  • previous history of gestational diabetes
  • history of high blood glucose, high triglycerides and/or low HDL cholesterol

Exclusion criteria

• fasting serum glucose ≥7.0mmol/L
• history of renal failure or liver disease
• serum urea or creatinine >1.8 times upper limit of normal (ULN)
• serum aspartate or alanine transaminase (AST,ALT) >1.5 times ULN
• current use of drug or drugs to treat diabetes or which influence glucose metabolism
• medical or surgical event requiring hospitalization within 3 months of randomization
• presence of any condition affecting nutrient absorption

Trial design

200 participants in 2 patient groups, including a placebo group

Dietary Supplement: Vitamin D

Active Comparator group

Description:

Vitamin D supplement 4000 IU/day for 6 months

Treatment:

Dietary Supplement: Vitamin D

Placebo

Placebo Comparator group

Description:

Placebo for 6 months

Treatment:

Dietary Supplement: Vitamin D