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Completed

NCT Number: NCT05161897

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

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.

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Key information

Conditions

PreDiabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Population Health Center Clinic George Mason University

Fairfax, Virginia, 22030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Individualized Nutrition Therapy

Other

Explained in arm/group description.

Primary outcomes

  1. Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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

  2. Change in insulin sensitivity [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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)

  3. Change in glucose tolerance [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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

Secondary outcomes

  1. Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days]

    Time frame: baseline, 10 days, 20 days, and 30 days

    As assessed by change in blood concentration of c-reactive protein (CRP)

  2. Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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)

  3. Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days]

    Time frame: baseline, 10 days, 20 days, and 30 days

    As assessed by blood concentrations of nitric oxide (NO) and endothelin-1 (ET-1)

  4. Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days]

    Time frame: baseline, 10 days, 20 days, and 30 days

    Change in blood pressure from baseline measures as assessed by measuring resting blood pressure

  5. Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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)

  6. Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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

  7. Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days]

    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

Sponsors and collaborators

Lead sponsor

George Mason University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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