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OpenTrials
Completed

NCT Number: NCT01729078

Dietary Interventions in Prediabetes

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.

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Key information

Conditions

Impaired Fasting Glucose Digestive System Diseases Fatty Liver Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Liver Diseases Liver Fat Metabolic Diseases Nutritional and Metabolic Diseases Pre Diabetes

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo clinic

Rochester, Minnesota, 55901, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary intervention

Dietary Supplement

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

Primary outcomes

  1. Changes in liver fat content after 12 weeks of intervention

    Time frame: 12 weeks

Secondary outcomes

  1. Change in glucose metabolism after 12 weeks of intervention

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 20, 2012
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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