Low-calorie Diet in Isolated Impaired Fasting Glucose

Isolated Impaired Fasting Glucose Clinical Trial

Official title:

Effect of Dietary Energy Restriction on Reversing Isolated Impaired Fasting Glucose: A Proof of Concept Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06451055
• Other study ID #: STUDY00007848
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: Sathish Thirunavukkarasu, PhD
• Phone: (404) 778-3771
• Email: sathish.thirunavukkarasu[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 i-IFG. Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Isolated Impaired Fasting Glucose
• Prediabetic State

Intervention

Behavioral:
• Low-calorie diet
LCD diet is designed to provide ~1300 kcal/day with a macronutrient composition of 55% carbohydrate, 13% fat, 25% protein, and 2% fiber.
• Routine dietary and physical activity habits
Participants will be asked to maintain their habitual dietary and physical activity habits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in kg	Weight will be measured using a digital weighing scale (Welch Ally-Scale-Tronix, NY, USA) with an accuracy to the nearest 0.1 kg	4 and 8 weeks
Primary	Fasting plasma glucose in mg/dl	Will be analyzed by enzymatic assays	4 and 8 weeks
Primary	Indices of ß-cell function	Will be assessed using the Insulinogenic index (IGI)	4 and 8 weeks
Primary	Indices of ß-cell function	Will be assessed using the Oral disposition index (DIo)	4 and 8 weeks
Primary	Indices of ß-cell function	Will be assessed using the Homeostatic model assessment of ß-cell function (HOMA-B)	4 and 8 weeks
Primary	Indices of hepatic insulin resistance	Will be assessed using the Hepatic insulin resistance index (HIRI)	4 and 8 weeks
Primary	Alanine aminotransferase (liver enzyme) in U/L	Will be analyzed with colorimetric assays	4 and 8 weeks
Secondary	Response rate	Response rate is defined as the proportion of individuals responding to the invitation sent via the Epic database.	Baseline
Secondary	Screening yield	Screening yield: Proportion of screened individuals meeting eligibility criteria.	Baseline
Secondary	Enrollment rate	Enrollment rate: Proportion of eligible individuals who enroll in the study.	Baseline
Secondary	Resource utilization	Resource utilization: Assessment of expenditures and staff time.	Throughout the study period, an average of 10 weeks
Secondary	Retention rate	Retention rate: Proportion of enrolled participants who complete the study.	4 and 8 weeks
Secondary	Intervention acceptability	Intervention acceptability will be assessed using the Theoretical Framework of Acceptability questionnaire. Scores range from 7 to 35. Higher scores indicate better acceptability among participants.	4 and 8 weeks
Secondary	Feasibility of intervention	Will be assessed using the Feasibility of Intervention Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better feasibility among participants.	4 and 8 weeks
Secondary	Intervention appropriateness	Will be assessed with the Intervention Appropriateness Measure questionnaire. Scores range from 4 to 20. Higher scores indicate better appropriateness among participants.	4 and 8 weeks
Secondary	Facilitators, barriers, acceptability, satisfaction, and participant experiences with the the intervention	Qualitative in-depth interviews	4 and 8 weeks