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

George Mason University (GMU)

Status: Completed

Conditions: Cardiovascular Diseases; PreDiabetes

Treatments: Other: Individualized Nutrition Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05161897

1825534-1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Individualized Nutrition Therapy