Cardiovascular Diseases, PreDiabetes
Conditions
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.
Interventions
OTHERIndividualized Nutrition Therapy
Explained in arm/group description.
Sponsors
George Mason University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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 * Anyone who refuses to wear the continuous glucose monitoring device as instructed * Anyone who will not fill out their food dairy and automated self-administered dietary assessment tool
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days] | 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] | 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] | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days] | baseline, 10 days, 20 days, and 30 days | Change in blood pressure from baseline measures as assessed by measuring resting blood pressure |
| 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 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) |
| Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days] | baseline, 10 days, 20 days, and 30 days | As assessed by change in blood concentration of c-reactive protein (CRP) |
| Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days] | 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 |
| Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days] | 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 |
| Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days] | 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) |
| Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days] | baseline, 10 days, 20 days, and 30 days | As assessed by blood concentrations of nitric oxide (NO) and endothelin-1 (ET-1) |
Countries
United States
Outcome results
None listed