Clinical trial NCT01113996: Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)
Official title: Optimization of Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training: Interventional Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
Gastric by-pass
Body composition
Nutrition
Physical activity
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-04-30
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect

Detailed description: Design: Open randomised controlled trial comparing, in obese patients after GBP, an additional oral intake of protein with or without a muscular-strengthening physical training programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as control (3 groups). Primary outcome: Variation at 6 months after GBP in total and appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of the study: 36 months. Duration of participation for one patient: 7 months. Number of centers: Monocentric study.

Eligibility criteria: Inclusion Criteria:

* Female gender
* Age between 18 and 60 years
* Planned obesity treatment by gastric bypass
* Written informed consent

Exclusion Criteria:

* Subject not affiliated with a social security scheme
* Refusal
* Regular follow-up not feasible
* Participation in a structured physical activity program
* Recent coronary event
* Uncontrolled hypertension
* proliferative diabetic retinopathy or disabling neuropathy, treatment by dialysis, orthopedic problems
* Pregnancy
* Specific food intolerance to protein products
* Abnormal cardiac stress test

Primary outcomes:
measure: Changes in fat-free mass at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Variation at 6 months after GBP of other body composition components
timeFrame: 6 months
measure: Variation at 6 months after GBP in dietary habits
timeFrame: 6 months
measure: Variation at 6 months after GBP in muscular strength and habitual physical activity
timeFrame: 6 months
measure: Variation at 6 months after GBP in quality of life and obesity co-morbidities
timeFrame: 6 months
measure: Variation at 6 months after GBP in obesity-associated inflammatory markers
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: GH-Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Michel OPPERT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellicha A, Ciangura C, Roda C, Torcivia A, Portero P, Oppert JM. Changes in Cardiorespiratory Fitness After Gastric Bypass: Relations with Accelerometry-Assessed Physical Activity. Obes Surg. 2019 Sep;29(9):2936-2941. doi: 10.1007/s11695-019-03932-2.
citation: Oppert JM, Bellicha A, Roda C, Bouillot JL, Torcivia A, Clement K, Poitou C, Ciangura C. Resistance Training and Protein Supplementation Increase Strength After Bariatric Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Nov;26(11):1709-1720. doi: 10.1002/oby.22317.