Roybal Diabetes Management Clinic
Los Angeles, California, 90022, United States
NCT Number: NCT04215328
The overall objective is to develop therapy for obesity and diabetes that is as effective as gastric bypass surgery but without the cost and safety concerns.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Los Angeles, California, 90022, United States
Gastric bypass leads to rapid, sustained diabetes remission in the majority of patients who undergo this procedure and is also highly effective therapy for obesity. However, currently <1% of medically-eligible patients undergo this or other bariatric operations due to cost and safety concerns. The approach is based on data suggesting that the benefit of gastric bypass is largely due to anatomical rearrangement of the intestine which leads to accelerated delivery of nutrients to the jejunum. This rerouting of nutrients stimulates the release of multiple neural, hormonal and enterokine responses that are associated with appetite suppression and improved glucose control. In this pilot proposal the question under investigation is whether repeated rapid delivery of a mixed meal directly to the jejunum can promote weight loss and glucose control.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses
Other names: Ensure Nutrition Shake® (Abbott Park, Illinois, U.S.A.)
Electrolyte Solution 500mLs by tube daily in 4 doses
Other names: Unflavored Pedialyte ® (Abbott Park, Illinois, U.S.A.)
Time frame: Day 0 to Day 14
Weight measured in kilograms taken before and immediately following the intervention period between the intervention and control group
Time frame: Day 0 to Day 14
Caloric intake measured in kcal. Determined by consumption of provided food.
Time frame: Day 0 to Day 14
Weight measured in kilgrams. Within group
Time frame: Day 0 to Day 14
Measured in centimeters. Between groups.
Time frame: Day 0 to Day 14
Measured in mmHg for both. Between groups.
Time frame: Day 0 to Day 14
Measured in beats per minute. Between groups.
Time frame: Day 0 to Day 14
Including GLP-1, PYY, CCK, C-peptide, and insulin. Between groups.
University of Southern California
Other
Facilitated Release of Endogenous Enterokines: An Ambulatory Prospective Randomized Controlled Trial
Acronym: F2G
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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