Insulin ResistanceNCT02098980
Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar
A study testing Vitamin D in people with Insulin Resistance, run by Supreme Council Of Health, Qatar at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteQatar
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha
Amin Jayyousi, M.D., 0097455530236, ajayyousi@hamad.qa
Amin Jayyousi, M.D.
About this study
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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- Vitamin D
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Vitamin D | Active comparator | Vitamin D supplement 4000 IU/day for 6 months Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo for 6 months Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Supreme Council Of Health, Qatar
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Al Thani, Supreme Council Of Health, Qatar
- Investigators
- Mohamed Al-Thani, Ph.D., Principal investigator, Supreme Council of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098980
- Sponsor's protocol ID
- INDDIQAT Trial
- Other IDs
- Vitamin D and Diabetes
- Status last verified
- Feb 2016
- First submitted
- 20 Mar 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32153959
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar
- ClinicalTrials.gov ID
- NCT02098980
- Acronym / sponsor ID
- INDDIQAT Trial
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Supreme Council Of Health, QatarOther government
- Study start
- May 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Vitamin D | Active comparator | Dietary Supplement: Vitamin DVitamin D supplement 4000 IU/day for 6 months |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin DPlacebo for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Placebo | Dietary supplement | Dietary Supplement: Vitamin D, Placebo |
Primary outcome
Insulin Resistance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 32153959Al 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Al-Thani, Ph.D. principal investigator
Supreme Council of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Insulin Resistance, run by Supreme Council Of Health, Qatar at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Al-Thani, Ph.D. (97444070100 ext. 0100, malthani@sch.gov.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02098980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.