Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- George Mason University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.
Investigators
Raedeh Basiri
Assistant Professor
George Mason University
Eligibility Criteria
Inclusion Criteria
- •Ages 45-65 years
- •Any race or ethnicity
- •Those who have or may have pre-diabetes (will be screened to confirm)
- •HbA1c level between 5.7%-6.4% (will be screened to confirm)
- •BMI between 25 and 39.9 kg/m2
- •Taking stable doses of antihypertensive and/or cholesterol-lowering medications for 3 months or more prior to being enrolled in the study
Exclusion Criteria
- •Pregnant or lactating
- •Individuals outside of the HbA1c and BMI inclusion ranges
- •Those with active cancer, thyroid, kidney, liver, and pancreatic diseases
- •Heavy cigarette smokers (25 cigarettes per day or more)
- •Heavy drinkers (\>12 alcoholic drinks per week on average)
- •Taking more than one hypoglycemic agent (blood sugar lowering medications)
- •Having major dietary restrictions
- •Participating in any weight loss or dietary program/taking prescribed appetite suppressants
- •Participating in another investigational study at the same time as this study
- •Anyone who refuses to follow dietary recommendations
Outcomes
Primary Outcomes
Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time Frame: baseline, 10 days, 20 days, and 30 days
Evaluating change in 24hr interstitial glucose concentrations and glycemic variability from baseline measure using a Continuous Glucose Monitoring (CGM) device
Change in insulin sensitivity [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time Frame: baseline, 10 days, 20 days, and 30 days
Change in insulin sensitivity from baseline measure will be assessed using the homeostatic model of insulin resistance (HOMA-IR) and insulin secretion (HOMA-β)
Change in glucose tolerance [Time Frame: baseline, 10 days, 20 days, and 30 days]
Time Frame: baseline, 10 days, 20 days, and 30 days
Change in glucose tolerance from baseline measures will be assessed using an oral glucose tolerance test
Secondary Outcomes
- Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)
- Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)
- Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)
- Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)
- Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)
- Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)
- Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days](baseline, 10 days, 20 days, and 30 days)