Impaired Fasting GlucoseNCT01729078
Dietary Interventions in Prediabetes
A study testing Dietary intervention in people with Impaired Fasting Glucose and Pre Diabetes, run by Mayo Clinic at 1 site in United States.
Trial summary
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Impaired Fasting Glucose, Pre Diabetes, Liver Fat
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired fasting glucose(100-125 mg/dl)
- HbA1c 5.7-6.4 %
- BMI 26-40 kg/sq.m
Who cannot join
- MRS contraindication
- Pregnant women
- Liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.
- Conditions
- Impaired Fasting Glucose, Pre Diabetes, Liver Fat
- Being tested
- Dietary intervention
- Medical subject headings
- Glucose Intolerance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionDietary supplement
three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
| Study group | Role | What they receive |
|---|---|---|
| high fat ( MUFA) diet | Experimental | intervention using high fat diet. Receives: Dietary Supplement: Dietary intervention |
| high carb/high fiber | Experimental | diet using high carb-high fiber with dry beans Receives: Dietary Supplement: Dietary intervention |
| high carb/low fat | Experimental | Habitual diet Receives: Dietary Supplement: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver fat content after 12 weeks of intervention
Measured: 12 weeks
Secondary outcomes (1)
Change in glucose metabolism after 12 weeks of intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionFeb 2014
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 Impaired Fasting GlucoseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Basu, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729078
- Sponsor's protocol ID
- 12-003216
- Status last verified
- Jul 2015
- First submitted
- 9 Nov 2012
- Last updated
- 29 Jul 2015
- Results posted
- No
Publications
Errazuriz I, Dube S, Slama M, Visentin R, Nayar S, O'Connor H, Cobelli C, Das SK, Basu A, Kremers WK, Port J, Basu R. Randomized Controlled Trial of a MUFA or Fiber-Rich Diet on Hepatic Fat in Prediabetes. J Clin Endocrinol Metab. 2017 May 1;102(5):1765-1774. doi: 10.1210/jc.2016-3722.
PubMed 28323952
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes
- ClinicalTrials.gov ID
- NCT01729078
- Acronym / sponsor ID
- 12-003216
- Conditions
- Impaired Fasting Glucose, Pre Diabetes, Liver Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Nov 2012 (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.
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre diabetes subjects. Subjects will be randomized to either high fat (olive oil supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets. Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high fat ( MUFA) diet | Experimental | Dietary Supplement: Dietary interventionintervention using high fat diet. |
| high carb/high fiber | Experimental | Dietary Supplement: Dietary interventiondiet using high carb-high fiber with dry beans |
| high carb/low fat | Experimental | Dietary Supplement: Dietary interventionHabitual diet |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Impaired fasting glucose(100-125 mg/dl)
- HbA1c 5.7-6.4 %
- BMI 26-40 kg/sq.m
Key exclusion criteria (3 listed)
- MRS contraindication
- Pregnant women
- Liver disease
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 |
|---|---|---|
| Dietary interventionthree different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber) | Dietary supplement | high carb/high fiber, high carb/low fat, high fat ( MUFA) diet |
Primary outcome
Changes in liver fat content after 12 weeks of intervention
Time frame: 12 weeks
1 secondary outcome
Change in glucose metabolism after 12 weeks of intervention
Time frame: 12 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 29 Jul 2015.
- Derived from this study: PubMed 28323952Errazuriz I, Dube S, Slama M, Visentin R, Nayar S, O'Connor H, Cobelli C, Das SK, Basu A, Kremers WK, Port J, Basu R. Randomized Controlled Trial of a MUFA or Fiber-Rich Diet on Hepatic Fat in Prediabetes. J Clin Endocrinol Metab. 2017 May 1;102(5):1765-1774. doi: 10.1210/jc.2016-3722.
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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 Dietary intervention in people with Impaired Fasting Glucose and Pre Diabetes, run by Mayo Clinic at 1 site in United States.
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 29 Jul 2015. 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 United States. 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?
Changes in liver fat content after 12 weeks of intervention (time frame: 12 weeks). 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 NCT01729078, 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 29 Jul 2015.