Not Yet RecruitingNot Applicable

Low-calorie Diet in Isolated Impaired Fasting Glucose

United States34 participantsStarted 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 range35 Years – 65 Years

SexALL

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)
✕. Chronic kidney disease
✕. Chronic liver disease (e.g., cirrhosis)
✕. Cancers
✕. Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
✕. Food allergies
✕. Participation in weight loss programs in the past six months

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

Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention

Trial details

NCT IDNCT06451055

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Sathish Thirunavukkarasu, PhD

(404) 778-3771 sathish.thirunavukkarasu@emory.edu

View on ClinicalTrials.gov More Isolated Impaired Fasting Glucose trials

Plain-language summary

Who can participate

Age range35 Years – 65 Years

SexALL

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)
✕. Chronic kidney disease
✕. Chronic liver disease (e.g., cirrhosis)
✕. Cancers
✕. Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
✕. Food allergies
✕. Participation in weight loss programs in the past six months

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

Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention