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Intervention Group for Cardiovascular Disease

N/A
Waitlist Available
Research Sponsored by George Mason University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10 days, 20 days, and 30 days
Awards & highlights

Study 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.

Eligible Conditions
  • Cardiovascular Disease
  • Prediabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10 days, 20 days, and 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 10 days, 20 days, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glucose tolerance [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in insulin sensitivity [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in interstitial glucose concentrations [Time Frame: baseline, 10 days, 20 days, and 30 days]
Secondary outcome measures
Change in antioxidant status [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in atherogenic risk ratios [Time Frame: baseline, 10 days, 20 days, and 30 days]
Change in blood pressure [Time Frame: baseline, 10 days, 20 days, and 30 days]
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
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.
Group II: Control GroupActive Control1 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.

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Who is running the clinical trial?

George Mason UniversityLead Sponsor
58 Previous Clinical Trials
48,764 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
Raedeh Basiri 2022. "Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161897.
~10 spots leftby Apr 2025
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