Diabetes Mellitus, Type 2NCT01906099
Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes
A study testing nutritional intervention and life style modification in people with Diabetes Mellitus, Type 2, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- nutritional intervention and life style modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIran
- Study dates
- Sep 2012to Mar 2013
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects aged more than 30 years
- no history of chronic diseases
- no use of blood glucose lowering drugs be wiling to participate to study
Who cannot join
- do not follow study protocol
- incidence of chronic diseases during the study
- to start use of blood glucose lowering drugs or to change dose and type of current medications
Trial locations and contacts
1 site in 1 country.
About this study
This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- nutritional intervention, life style modification
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional interventionOther
life style modificationOther
| Study group | Role | What they receive |
|---|---|---|
| legume enriched diet | Experimental | legume consumption, 4 servings per week, for 6 weeks Receives: Other: nutritional intervention |
| healthy dietary recommendations | Active comparator | no nutritional intervention Receives: Other: life style modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose (mg/dl)
amounts of FBG
Measured: 14 weeks
Secondary outcomes (5)
Hemoglobin A1C (%)
amounts of HbA1C
Measured: 14 weeks
Total cholesterol (mg/dl)
amounts of TC
Measured: 14 weeks
Low Density Lipoprotein (mg/dl)
amounts of LDL
Measured: 14 weeks
High Density Lipoprotein (mg/dl)
amounts of HDL
Measured: 14 weeks
Triglyceride (mg/dl)
amounts of TG
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Azadbakht, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906099
- Sponsor's protocol ID
- legume intake and CVD risks
- Status last verified
- Jul 2013
- First submitted
- 9 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Legume Intake on Cardiovascular Risk Factors Among Adults at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT01906099
- Acronym / sponsor ID
- legume intake and CVD risks
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Jul 2013 (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.
This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| legume enriched diet | Experimental | Other: nutritional interventionlegume consumption, 4 servings per week, for 6 weeks |
| healthy dietary recommendations | Active comparator | Other: life style modificationno nutritional intervention |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects aged more than 30 years
- no history of chronic diseases
- no use of blood glucose lowering drugs be wiling to participate to study
Key exclusion criteria (3 listed)
- do not follow study protocol
- incidence of chronic diseases during the study
- to start use of blood glucose lowering drugs or to change dose and type of current medications
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 |
|---|---|---|
| nutritional intervention | Other | legume enriched diet |
| life style modification | Other | healthy dietary recommendations |
Primary outcome
Fasting blood glucose (mg/dl)
Time frame: 14 weeks
amounts of FBG
5 secondary outcomes
Hemoglobin A1C (%)
Time frame: 14 weeks
Total cholesterol (mg/dl)
Time frame: 14 weeks
Low Density Lipoprotein (mg/dl)
Time frame: 14 weeks
High Density Lipoprotein (mg/dl)
Time frame: 14 weeks
Triglyceride (mg/dl)
Time frame: 14 weeks
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 23 Jul 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional intervention and life style modification in people with Diabetes Mellitus, Type 2, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Jul 2013. 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 Iran. 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. 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?
Fasting blood glucose (mg/dl) (time frame: 14 weeks). 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 23 Jul 2013.