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Dietary Interventions in Prediabetes

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ClinicalTrials.gov Identifier: NCT01729078
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Rita Basu, Mayo Clinic

Brief 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. 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 or disease Intervention/treatment Phase
Impaired Fasting Glucose Pre Diabetes Liver Fat Dietary Supplement: Dietary intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Changes in liver fat content after 12 weeks of intervention [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in glucose metabolism after 12 weeks of intervention [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729078


Locations
United States, Minnesota
Mayo clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic

Responsible Party: Rita Basu, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01729078     History of Changes
Other Study ID Numbers: 12-003216
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

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