Normal and Overweight Individuals at High-risk of Diabetes
Conditions
Brief summary
Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.
Interventions
BEHAVIORALFasting arm
Study participants will fast one day per week for 12 weeks
BEHAVIORALWeight maintenance
Study participants will be counseled to maintain body weight
BEHAVIORALCounseling
Study participants will be counseled on optimal diet and activity recommendations for maintaining/achieving a normal BMI
Sponsors
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, controlled study
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women, ages 21-45 years 2. BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2 3. Normal thyroid function 4. Regular menses (women) 5. At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes
Exclusion criteria
1. Any chronic diseases including hypertension and Type 2 diabetes mellitus 2. Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL\>190 or an estimated 10-year ASCVD risk of \>7.5%) 3. Chronic medications, including oral contraceptive pills 4. Pregnant and/or breastfeeding 5. History of an eating disorder 6. 25-OH vitamin D level \< 20 ng/mL 7. Active substance abuse, including alcohol 8. Subjects with a prior history of intermittent fasting 9. The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Triglyceride carbon content and degree of saturation | Baseline, 3 months | Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits |
| Trabecular bone microarchitecture | Baseline, 3 months | Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity | Baseline, 3 months | Change in insulin sensitivity as assessed by hyperinsulinemic-euglycemic clamp between Baseline and Final Intervention visits |
Countries
United States
Contacts
CONTACTPouneh Fazeli, MD
PRINCIPAL_INVESTIGATORPouneh Fazeli, MD
University of Pittsburgh
Outcome results
None listed