Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes

Cardiovascular Diseases Clinical Trial

Official title:

Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161897
• Other study ID #: 1825534-1
• Status: Completed
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: December 14, 2023

Study information

• Verified date: May 2024
• Source: George Mason University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• PreDiabetes

Intervention

Other:
• Individualized Nutrition Therapy
Explained in arm/group description.

Locations

Country	Name	City	State
United States	Population Health Center Clinic George Mason University	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
George Mason University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline, 10 days, 20 days, and 30 days
Primary	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-ß)	baseline, 10 days, 20 days, and 30 days
Primary	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	baseline, 10 days, 20 days, and 30 days
Secondary	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)	baseline, 10 days, 20 days, and 30 days
Secondary	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)	baseline, 10 days, 20 days, and 30 days
Secondary	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)	baseline, 10 days, 20 days, and 30 days
Secondary	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	baseline, 10 days, 20 days, and 30 days
Secondary	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)	baseline, 10 days, 20 days, and 30 days
Secondary	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	baseline, 10 days, 20 days, and 30 days
Secondary	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	baseline, 10 days, 20 days, and 30 days