Back to resultsDietary Interventions in Prediabetes
Primary Purpose
Impaired Fasting Glucose, Pre Diabetes, Liver Fat
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional basic science trial for Impaired Fasting Glucose
Eligibility 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
Sites / Locations
- Mayo clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
high fat ( MUFA) diet
high carb/high fiber
high carb/low fat
Arm Description
intervention using high fat diet.
diet using high carb-high fiber with dry beans
Habitual diet
Outcomes
Primary Outcome Measures
Changes in liver fat content after 12 weeks of intervention
Secondary Outcome Measures
Change in glucose metabolism after 12 weeks of intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01729078
Brief Title
Dietary Interventions in Prediabetes
Official Title
The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Fasting Glucose, Pre Diabetes, Liver Fat
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high fat ( MUFA) diet
Arm Type
Experimental
Arm Description
intervention using high fat diet.
Arm Title
high carb/high fiber
Arm Type
Experimental
Arm Description
diet using high carb-high fiber with dry beans
Arm Title
high carb/low fat
Arm Type
Experimental
Arm Description
Habitual diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary intervention
Intervention Description
three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
Primary Outcome Measure Information:
Title
Changes in liver fat content after 12 weeks of intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in glucose metabolism after 12 weeks of intervention
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mayo clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28323952
Citation
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.
Results Reference
derived
Learn more about this trial
Dietary Interventions in Prediabetes
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