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

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ClinicalTrials.gov Identifier: NCT02098980
Recruitment Status : Unknown
Verified February 2016 by Mohamed Al Thani, Supreme Council Of Health, Qatar.
Recruitment status was:  Recruiting
First Posted : March 28, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Mohamed Al Thani, Supreme Council Of Health, Qatar

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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Dietary Supplement: Vitamin D Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar
Study Start Date : May 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Dietary Supplement: Vitamin D
Vitamin D supplement 4000 IU/day for 6 months
Dietary Supplement: Vitamin D
Other Name: Placebo
Placebo Comparator: Placebo
Placebo for 6 months
Dietary Supplement: Vitamin D
Other Name: Placebo



Primary Outcome Measures :
  1. Insulin Resistance [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098980


Contacts
Contact: Mohamed Al-Thani, Ph.D. 97444070100 ext 0100 malthani@sch.gov.qa

Locations
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
Contact: Amin Jayyousi, M.D.    0097455530236    ajayyousi@hamad.qa   
Sub-Investigator: Amin Jayyousi, M.D.         
Sponsors and Collaborators
Supreme Council Of Health, Qatar
Investigators
Principal Investigator: Mohamed Al-Thani, Ph.D. Supreme Council of Health

Responsible Party: Mohamed Al Thani, Doctor, Supreme Council Of Health, Qatar
ClinicalTrials.gov Identifier: NCT02098980     History of Changes
Other Study ID Numbers: INDDIQAT Trial
Vitamin D and Diabetes ( Other Grant/Funding Number: Qatar National Research Fund/ NPRP No.: 6-273-3-067 )
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents