Status:
COMPLETED
2-A-Day Study: Twice a Day Meals Study.
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
PreDiabetes
Eligibility:
MALE
30-70 years
Phase:
NA
Brief Summary
Caloric restriction increases lifespan and/or healthspan across multiple species. However implementation of long-term CR in humans is problematic and unacceptable to many individuals. As a result, int...
Detailed Description
Caloric restriction (CR) increases lifespan and/or healthspan across multiple species including non-human primates. However, implementation of long-term CR in humans is problematic and unacceptable to...
Eligibility Criteria
Inclusion
- ● Men, age 30-70 years. In this preliminary study, recruitment is limited to men because data from the relevant animal studies showed marked sexual dimorphism, with more pronounced metabolic effects in males. Future studies will include both males and females.
- IFG or IGT based on 75g OGTT (fasting plasma glucose 100 -125 mg/dl and/or 2-hr glucose between 140 - 199 mg/dl); Or diabetes (FPG \> 126 mg/dl or 2 hr glucose \> 200 mg/dl) not on treatment and with HbA1c \< 6.8% can also be enrolled.
- BMI 25-35 kg/m2
Exclusion
- Type 2 diabetes with A1C ≥6.8% or on drug treatment; Type 1 diabetes
- Treatment with drugs known to influence glucose metabolism (diabetes medications, systemic glucocorticoids, niacin \> 500 mg/day)
- Current smoking, alcohol or drug abuse
- Vigorous habitual physical activity (e.g., marathon runner, heavy weights trainers)
- Subjects with symptomatic gastrointestinal disorders or intolerance (e.g., food allergies, lactose intolerance, gluten sensitivity, etc.) or other conditions requiring special diet or meal timing.
- Subjects with serious chronic illness: severe (activity limiting) COPD, NYHA class 3 or 4 heart failure, kidney disease (eGFR\<45ml/min), liver enzyme abnormalities (ALT \> 2 times ULN), stroke, MI or ACS within last 6 months, cancer or HIV disease under treatment.
- Any other disease/condition that the investigator believes may interfere with participation in the study (e.g., eating disorder).
- Unstable weight conditions: gain or loss of \> 5 pounds or 2.5% body weight in past 3 months.
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03809299
Start Date
June 20 2019
End Date
June 16 2022
Last Update
February 13 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461