PrediabetesNCT02250066
Prevention of Type 2 Diabetes Mellitus by Changes in Diet
A study testing Diet in people with Prediabetes, run by Ilam University of Medical Sciences.
Trial summary
investigators evaluated the efficacy of two types of diet with different macronutrients, on prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prediabetes
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Apr 2014
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Adults over 20 years Exclusion Criteria: Diet therapy; severe physical activity; accompanying diseases such as cancer which reduce their life expectancy; receiving thiazide diuretics; receiving systemic ß blockers; receiving glucocorticoids; receiving nicotinic acid; receiving weight lowering drugs
About this study
Official title: Effect of Diet Therapy on Prevention of Type 2 Diabetes Mellitus Among 322 Adults Over 20 Years With Abnormal Glucose Metabolism
investigators evaluated the efficacy of two types of diet with different macronutrients, on prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or control group (n=109) and followed for 2 years. For calculating daily energy requirement in subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal body weight with no attempt for losing body weight. Control group were encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and saturated fat to less than 10 percent of total energy. The primary outcome variable was incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association criteria.
Read the detailed description
322 participants were randomized and stratified into a control group and two study groups according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were anthropometric measurements, food diary and laboratory exams. Anthropometric measurements were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA in this group was olive oil. In the intervention groups diet regimen was written for each participant by a registered dietitian. Group three or the control group was encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy consumption and saturated fat to less than 10 percent of total energy.
- Conditions
- Prediabetes
- Being tested
- Diet
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Study group 1 received high monounsaturated fat diet Study group2 received high carbohydrate diet Control group was encouraged to follow the Food Guide Pyramid
| Study group | Role | What they receive |
|---|---|---|
| Study group 1 | Other | Received high monounsaturated fat diet Receives: Other: Diet |
| Study group 2 | Other | Received high carbohydrate diet Receives: Other: Diet |
| Control Group | No intervention | Control group was encouraged to follow the Food Guide Pyramid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Diabetes in 322 Subjects with Prediabetes
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilam University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250066
- Sponsor's protocol ID
- IlamUMS
- Status last verified
- Jul 2017
- First submitted
- 17 Sep 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet Therapy on Prevention of Type 2 Diabetes Mellitus Among 322 Adults Over 20 Years With Abnormal Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02250066
- Acronym / sponsor ID
- IlamUMS
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Ilam University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 26 Sep 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.
investigators evaluated the efficacy of two types of diet with different macronutrients, on prevention or delaying the onset of type 2 diabetes in subjects with either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). 322 subjects with prediabetes were randomly assigned to high monounsaturated fat diet (n=107), high carbohydrate diet (n=106) or control group (n=109) and followed for 2 years. For calculating daily energy requirement in subjects with BMI≥25 kg/m2 the weight was adjusted with the use of 110 percent of the ideal body weight with no attempt for losing body weight. Control group were encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30% of energy consumed and saturated fat to less than 10 percent of total energy. The primary outcome variable was incidence of type 2 diabetes mellitus, diagnosed by the latest American Diabetic Association criteria.
Detailed description
322 participants were randomized and stratified into a control group and two study groups according to sex, age, body mass index (BMI), IFG and IGT or both. Baseline assessments were anthropometric measurements, food diary and laboratory exams. Anthropometric measurements were repeated annually. Blood sample tests measured fasting blood glucose, glucose two hours after ingestion of 75 g glucose, high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride (TG), which were analyzed in the laboratory of the only university hospital in the city. The same assessments were repeated annually (at 12 and 24 months) in all groups. Daily energy requirement was calculated by multiplying 30-35 Kcal per Kg body weight for each participant. For patients with BMI ≥25 kg/m2, the weight was adjusted with use of 110 percent of the ideal body weight. Diet in HCD group was 15% from protein, 30% from fat (10% MUFA, 10% PUFA, 10% SFA) and 55% from carbohydrate. Diet in HMD group was 15% from protein, 45% from fat (25% MUFA, 10% PUFA, 10% SFA) and 40% from carbohydrate. Source of MUFA in this group was olive oil. In the intervention groups diet regimen was written for each participant by a registered dietitian. Group three or the control group was encouraged to follow the Food Guide Pyramid and reduce their fat intake to less than 30 percent of energy consumption and saturated fat to less than 10 percent of total energy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | Other | Other: DietReceived high monounsaturated fat diet |
| Study group 2 | Other | Other: DietReceived high carbohydrate diet |
| Control Group | No intervention | –Control group was encouraged to follow the Food Guide Pyramid |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DietStudy group 1 received high monounsaturated fat diet Study group2 received high carbohydrate diet Control group was encouraged to follow the Food Guide Pyramid | Other | Study group 1, Study group 2 |
Primary outcome
Incidence of Diabetes in 322 Subjects with Prediabetes
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Prediabetes, run by Ilam University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Diabetes in 322 Subjects with Prediabetes (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2017.