An observational study in Healthy Volunteers, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Withdrawn. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
Background:
Objective:
Eligibility:
Design:
Lifestyle interventions can result in weight loss, but most people experience a plateau after 6-10 months when weight stabilizes and many subsequently regain weight over the subsequent months. This pattern of weight plateau and regain is typical and appears to be independent of the lifestyle intervention used. The apparent resistance to further weight loss in not well understood.
We recently demonstrated that participants engaged in an intensive intervention employing caloric restriction and vigorous exercise had a profound slowing of metabolism that was significantly greater than expected due to weight loss alone. This phenomenon is called metabolic adaptation and has also been observed following weight loss through caloric restriction without exercise and may persist long after weight loss has ceased. Metabolic adaptation has been hypothesized to limit weight loss and predispose individuals to weight regain, but this has yet to be demonstrated and the concept is controversial. In addition to the metabolic adaptations to weight loss, the brain also adapts in ways that enhance the activation of reward regions in response to palatable food cues and their receipt. In particular, the brain s dopamine circuitry is believed to be altered in obesity and it is presently unclear how this pathway responds to a weight loss intervention in humans.
The primary aims of this study are to investigate the metabolic and neural adaptations in 60 obese adult volunteers participating in lifestyle interventions resulting in weight loss through a structured meal replacement program or caloric restriction plus vigorous exercise. The secondary aim is to determine whether the magnitude of metabolic adaptation or the changes in the brain s reward circuitry or responsiveness to food cues are related to the ubiquitous weight loss plateau after 6-10 months or the rate of weight regain in the subsequent months.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
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EXCLUSION CRITERIA:
Hypertension if
To measure metabolic and neural adaptations after 4-12 weeks, 6-10 months, and 22-26 months following the start of a lifestyle intervention resulting in weight loss.
Time frame: ongoing
To determine whether the degree of metabolic or neural adaptation at 4-12 weeks is correlated with the weight plateau at 6-10 months or the rate of weight regain in the subsequent months.
Time frame: ongoing
To investigate changes in circulating hormone and metabolites that correlate with metabolic and neural adaptations as well as changes in appetitive behaviors following a lifestyle intervention resulting in weight loss.
Time frame: ongoing
No study locations are listed for this record.
This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)