WithdrawnNot Applicable

Low-calorie Diet in Isolated Impaired Fasting Glucose

Stopped: Due to operational issues

United States0Started 2026-06-01

Plain-language summary

This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 35 to 65 years
. Overweight (body mass index (BMI) ≥25 to \<29 kg/m² or ≥23 to \<29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²)
. Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity)
. Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool

Exclusion criteria

. Diagnosed with type 1 or type 2 diabetes
. Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response rate

Timeframe: Baseline

Screening yield

Timeframe: Baseline

Enrollment rate

Timeframe: Baseline

Resource utilization

Timeframe: Throughout the study period, an average of 10 weeks

Retention rate

Timeframe: 4 and 8 weeks

Intervention acceptability

Timeframe: 4 and 8 weeks

Feasibility of intervention

Timeframe: 4 and 8 weeks

Intervention appropriateness

Timeframe: 4 and 8 weeks

Trial details

NCT IDNCT06451055

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

View on ClinicalTrials.gov More Isolated Impaired Fasting Glucose trials

Plain-language summary

Who can participate

Age range

35 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 35 to 65 years
. Overweight (body mass index (BMI) ≥25 to \<29 kg/m² or ≥23 to \<29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²)
. Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity)
. Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool

Exclusion criteria

. Diagnosed with type 1 or type 2 diabetes
. Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)

What they're measuring

Response rate

Timeframe: Baseline

Screening yield

Timeframe: Baseline

Enrollment rate

Timeframe: Baseline

Resource utilization

Timeframe: Throughout the study period, an average of 10 weeks

Retention rate

Timeframe: 4 and 8 weeks

Intervention acceptability

Timeframe: 4 and 8 weeks

Feasibility of intervention

Timeframe: 4 and 8 weeks

Intervention appropriateness

Timeframe: 4 and 8 weeks