Clinical trial NCT05161897: Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
Official title: Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Cardiovascular Diseases
Lead sponsor: George Mason University
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in insulin sensitivity [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in glucose tolerance [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
Secondary outcomes:
measure: Change in inflammation status [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in lipid profiles [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in markers of endothelial function [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
measure: Change in dietary intake [Time Frame: baseline, 10 days, 20 days, and 30 days]
timeFrame: baseline, 10 days, 20 days, and 30 days
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Population Health Center Clinic George Mason University
state: Virginia
Study officials:
affiliation: George Mason University
name: Raedeh Basiri, PhD
role: PRINCIPAL_INVESTIGATOR
References: