Status:
UNKNOWN
Adaptive Responses to Overfeeding and Weight
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
University of Colorado, Boulder
Conditions:
Obesity
Eligibility:
All Genders
30-50 years
Phase:
NA
Brief Summary
To more effectively address the problem of weight regain following weight loss for obese individuals, this study will evaluate the underlying biology of the reduced obese state. In depth studies of ap...
Detailed Description
The persistent problem of weight regain following weight loss is perhaps the most significant barrier to addressing the current obesity epidemic. The biological drive to regain weight following weight...
Eligibility Criteria
Inclusion
- Inclusion criteria.
- BMI of 30-38 kg/m2 and weight stable over the previous 6 months.
- Satisfied with current weight and not planning to lose weight at the time of enrollment (persons with obesity control group) -or- not satisfied with current weight and motivated to lose weight at the time of enrollment (reduced obese groups)
- No more than 90 min or 3 bouts of planned physical activity/wk.
- Pass a medical and physical screening performed by the study physician.
- Reporting a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100 h and getting up between 0600 and 0900 h with \>7 h and \<9.25 h in bed.
- Live or work within 45 minutes of the CU-AMC (reduced obese groups only) (exceptions may be made at the discretion of the Study PI on a case by case basis for highly motivated subjects).
- Own a smartphone (Android or Apple iOS).
- For Females
- Not currently pregnant or lactating
- Not pregnant within the past 6 months
- Not planning to become pregnant in the next 12 months; sexually active women of childbearing potential may be enrolled if they use a reliable means of contraception
- Capable and willing to provide informed consent, understand exclusion criteria, and accept the randomized group assignment (reduced obese groups)
- Exclusion criteria.
- Being considered unsafe to participate as determined by the study physician;
- Taking medications affecting weight, triglycerides, or energy intake/energy expenditure in the last 3 months;
- Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
- Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
- History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
- Score \> 18 on Beck Depression Index (BDI) will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
- Use of a continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea (OSA). A score of \>10 on the Epworth sleepiness scale or \>5 on the Pittsburgh Sleep Quality Index will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
- Being positive for human immunodeficiency virus or hepatitis B or C;
- History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve);
- Being a smoker or having been a smoker in the previous 6 months;
- Abnormal eating patterns identified by registered dietitian interview (dietary fat\<15%, dietary fat\>45%, dietary protein \>30%);
- Working night shifts;
- Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
- Traveling \> 2 time zones 2 weeks prior to an inpatient CTRC study visit;
- Currently participating in any formal weight loss or physical activity programs or clinical trials.
Exclusion
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03857048
Start Date
February 15 2019
End Date
January 1 2024
Last Update
April 7 2023
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80045