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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Explained in arm/group description.
Population Health Center Clinic George Mason University
Fairfax, Virginia, United States
Change in interstitial glucose concentrations [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
Time frame: baseline, 10 days, 20 days, and 30 days
Change in insulin sensitivity [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)
Time frame: baseline, 10 days, 20 days, and 30 days
Change in glucose tolerance [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
Time frame: baseline, 10 days, 20 days, and 30 days
Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days]
As assessed by change in blood concentration of c-reactive protein (CRP)
Time frame: baseline, 10 days, 20 days, and 30 days
Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days]
As assessed by change in blood concentration of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and oxidized LDL (ox-LDL)
Time frame: baseline, 10 days, 20 days, and 30 days
Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days]
As assessed by blood concentrations of nitric oxide (NO) and endothelin-1 (ET-1)
Time frame: baseline, 10 days, 20 days, and 30 days
Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in blood pressure from baseline measures as assessed by measuring resting blood pressure
Time frame: baseline, 10 days, 20 days, and 30 days
Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in atherogenic risk ratios from baseline measures as assessed by (AIP) = Log (TG/HDL-C), CRI-I(TC/HDL-C), CRI-II(LDL-C/HDL-C), AC(TC-HDL-C/HDL-C)
Time frame: baseline, 10 days, 20 days, and 30 days
Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in antioxidant status from baseline measure as assessed by measuring total antioxidant capacity (TAC) in blood
Time frame: baseline, 10 days, 20 days, and 30 days
Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in dietary intake from baseline measures using data from ASA24 survey for one day in each time frame
Time frame: baseline, 10 days, 20 days, and 30 days
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