Dietary Interventions in Prediabetes

NCT ID: NCT01729078

Last Updated: 2015-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Impaired Fasting Glucose Pre Diabetes Liver Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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high fat ( MUFA) diet

intervention using high fat diet.

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type DIETARY_SUPPLEMENT

three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

high carb/high fiber

diet using high carb-high fiber with dry beans

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type DIETARY_SUPPLEMENT

three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

high carb/low fat

Habitual diet

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type DIETARY_SUPPLEMENT

three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

Interventions

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Dietary intervention

three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Impaired fasting glucose(100-125 mg/dl)
* HbA1c 5.7-6.4 %
* BMI 26-40 kg/sq.m

Exclusion Criteria

* MRS contraindication
* Pregnant women
* Liver disease
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Rita Basu

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28323952 (View on PubMed)

Other Identifiers

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12-003216

Identifier Type: -

Identifier Source: org_study_id

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