Dietary Interventions in Prediabetes

Pre Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729078
• Other study ID #: 12-003216
• Status: Completed
• Phase: N/A
• First received: November 9, 2012
• Last updated: July 27, 2015
• Start date: October 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Fasting Glucose
• Liver Fat
• Pre Diabetes
• Prediabetic State

Intervention

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)

Locations

Country	Name	City	State
United States	Mayo clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in liver fat content after 12 weeks of intervention		12 weeks	No
Secondary	Change in glucose metabolism after 12 weeks of intervention		12 weeks	No