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

NCT05161897 | Completed

• 1 other identifier: 1825534-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

  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

  baseline, 10 days, 20 days, and 30 days

Secondary Outcomes (7)

• Change in inflammation status [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 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

Study Arms (2)

Control Group

NO INTERVENTION

This arm will receive generalized nutrition therapy throughout the study. Participants will receive dietary recommendations based on their needs and will be educated about the recommended amount of carbohydrates for each meal and the carbohydrate choices. Participants will also be provided with a CGM device; however, participants will be blind to the CGM recordings until the end of the study.

Intervention Group

EXPERIMENTAL

This arm will receive both individualized nutrition therapy and generalized nutrition therapy throughout the study. Participants will receive dietary recommendations based on their needs and will be educated about the recommended amount of carbohydrates for each meal and the carb choices. Participants will also be provided with a CGM device and will be educated to review their blood glucose measurements and record above range measures along with time, types and amount of food items consumed, cooking method, and any type of physical activity within one hour before or after the meal. This information will be reviewed by one of the research staff at each visit and will be used to set individualized goals for modifying diet and controlling blood glucose. Participants will visit every 10 days for 30 days to conduct measurements, replace their CGM, set new goals based on their food diary and CGM recordings, and receive further dietary recommendations.

Other: Individualized Nutrition Therapy

Interventions

Individualized Nutrition Therapy OTHER

Explained in arm/group description.

Intervention Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating
• 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

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

Population Health Center Clinic George Mason University

Fairfax, Virginia, 22030, United States

Location

MeSH Terms

Conditions

Prediabetic State; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Raedeh Basiri, PhD

  George Mason University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 17, 2021
• Study Start: August 25, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)