Clinical trial NCT06451055: Low-calorie Diet in Isolated Impaired Fasting Glucose
Official title: Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Isolated Impaired Fasting Glucose
Keywords: Low-calorie diet
Prediabetes
Overweight
Obesity
Fasting hyperglycemia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This proof-of-concept randomized controlled trial (RCT) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. Intervention participants will adhere to an 8-week low-calorie dietary (LCD) regimen (\~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). Control participants will maintain their habitual dietary habits and physical activity levels. Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and alanine aminotransferase levels. Secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. Qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the LCD intervention.

Eligibility criteria: Inclusion Criteria:

1. Aged 35 to 65 years
2. 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)
3. Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity)
4. Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool

Exclusion Criteria:

1. Diagnosed with type 1 or type 2 diabetes
2. Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)
3. Chronic kidney disease
4. Chronic liver disease (e.g., cirrhosis)
5. Cancers
6. Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
7. Food allergies
8. Participation in weight loss programs in the past six months
9. Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet)
10. Participation in any exercise programs in the past six months
11. Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics)
12. Previous bariatric surgery or plan to have bariatric surgery during the study period
13. Planning to relocate during the study period
14. Intending to fast during the study period for religious or other reasons
15. Pregnancy or planning to become pregnant during the study period
16. Breastfeeding
17. Non-English speaker

Primary outcomes:
measure: Response rate
timeFrame: Baseline
measure: Screening yield
timeFrame: Baseline
measure: Enrollment rate
timeFrame: Baseline
measure: Resource utilization
timeFrame: Throughout the study period, an average of 10 weeks
measure: Retention rate
timeFrame: 4 and 8 weeks
measure: Intervention acceptability
timeFrame: 4 and 8 weeks
measure: Feasibility of intervention
timeFrame: 4 and 8 weeks
measure: Intervention appropriateness
timeFrame: 4 and 8 weeks
measure: Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention
timeFrame: 4 and 8 weeks
Secondary outcomes:
measure: Weight in kg
timeFrame: 4 and 8 weeks
measure: Fasting plasma glucose in mg/dl
timeFrame: 4 and 8 weeks
measure: Indices of ß-cell function
timeFrame: 4 and 8 weeks
measure: ß-cell function assessed by Oral Disposition Index (DI(O))
timeFrame: 4 and 8 weeks
measure: ß-cell function assessed by Homeostatic Model Assessment of ß-cell Function (HOMA-B)
timeFrame: 4 and 8 weeks
measure: Indices of hepatic insulin resistance
timeFrame: 4 and 8 weeks
measure: Alanine aminotransferase (liver enzyme) in U/L
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Clinical & Translational Science Alliance (CTSA) Clinical Research Centers (GCRCs)
state: Georgia
Study officials:
affiliation: Emory University
name: Sathish Thirunavukkarasu, PhD
role: PRINCIPAL_INVESTIGATOR
References: