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Dietary Interventions in Prediabetes

This study is currently recruiting participants.
Verified November 2012 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Rita Basu, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01729078
First received: November 9, 2012
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Impaired Fasting Glucose
Pre Diabetes
Liver Fat
 Dietary Supplement: Dietary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Changes in liver fat content after 12 weeks of intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glucose metabolism after 12 weeks of intervention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: high fat ( MUFA) diet
intervention using high fat diet.
 Dietary Supplement: Dietary intervention
three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
Experimental: high carb/high fiber
diet using high carb-high fiber with dry beans
 Dietary Supplement: Dietary intervention
three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
Experimental: high carb/low fat
Habitual diet
 Dietary Supplement: Dietary intervention
three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729078

Contacts
Contact: RIta Basu, MD 507-255-4230 basu.rita@mayo.edu

Locations
United States, Minnesota
Mayo clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Rita Basu, MD         basu.rita@mayo.edu    
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Rita Basu, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01729078     History of Changes
Other Study ID Numbers: 12-003216
Study First Received: November 9, 2012
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on May 21, 2013