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

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.

Study Overview

• Status: Unknown
• Conditions: Insulin Resistance
• Intervention / Treatment: Dietary supplement: Vitamin D

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Al-Thani, Ph.D.; Phone Number: 0100 97444070100; Email: malthani@sch.gov.qa

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • Hamad medical corporation
    • Contact: Amin Jayyousi, M.D.; Phone Number: 0097455530236; Email: ajayyousi@hamad.qa
    • Sub-Investigator: Amin Jayyousi, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dietary Supplement: Vitamin D; Vitamin D supplement 4000 IU/day for 6 months	Dietary supplement: Vitamin D; Other Names: Placebo
PLACEBO_COMPARATOR: Placebo; Placebo for 6 months	Dietary supplement: Vitamin D; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insulin Resistance	6 months

Collaborators and Investigators

• Sponsor: Supreme Council Of Health, Qatar
• Investigators: Principal Investigator: Mohamed Al-Thani, Ph.D., Supreme Council of Health

Publications and helpful links

General Publications

• Al Thani M, Sadoun E, Sofroniou A, Jayyousi A, Baagar KAM, Al Hammaq A, Vinodson B, Akram H, Bhatti ZS, Nasser HS, Leventakou V. The effect of vitamin D supplementation on the glycemic control of pre-diabetic Qatari patients in a randomized control trial. BMC Nutr. 2019 Oct 10;5:46. doi: 10.1186/s40795-019-0311-x. eCollection 2019.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (ESTIMATE): March 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: INDDIQAT Trial; Vitamin D and Diabetes (OTHER_GRANT: Qatar National Research Fund/ NPRP No.: 6-273-3-067)