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

NCT02098980 | Unknown

• 2 other identifiers: INDDIQAT TrialVitamin D and Diabetes
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance

  6 months

Study Arms (2)

Dietary Supplement: Vitamin D

ACTIVE COMPARATOR

Vitamin D supplement 4000 IU/day for 6 months

Dietary Supplement: Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo for 6 months

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Also known as: Placebo

Dietary Supplement: Vitamin D; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Supreme Council Of Health, Qatar: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

Related Publications (1)

• 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.

  PMID: 32153959 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohamed Al-Thani, Ph.D.

  Supreme Council of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Al-Thani, Ph.D.

CONTACT

97444070100; malthani@sch.gov.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 28, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

QA (1)