Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)
This study is currently recruiting participants.
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01113996
First received: April 29, 2010
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Protein supplementation and strength training Dietary Supplement: Protein supplementation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Optimization of Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training: Interventional Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Changes in fat-free mass at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Variation at 6 months after GBP of other body composition components [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Variation at 6 months after GBP in dietary habits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Variation at 6 months after GBP in muscular strength and habitual physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Variation at 6 months after GBP in quality of life and obesity co-morbidities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Variation at 6 months after GBP in obesity-associated inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 83 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Standard treatment - usual care | |
| Experimental: Protein supplementation |
Dietary Supplement: Protein supplementation
Protein supplementation
Other Name: Protein supplementation
|
| Experimental: Protein supplementation and strength training |
Behavioral: Protein supplementation and strength training
Protein supplementation and strength training
Other Name: Protein supplementation and strength training
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113996
Locations
| France | |
| GH-Pitié-Salpêtrière | Recruiting |
| Paris, France, 75013 | |
| Contact: JM OPPERT, MD, PhD 01 42 17 79 48 jean-michel.oppert@psl.aphp.fr | |
| Principal Investigator: JM OPPERT, MD,PhD | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Jean Michel OPPERT, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01113996 History of Changes |
| Other Study ID Numbers: | P081108 |
| Study First Received: | April 29, 2010 |
| Last Updated: | October 30, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Obesity Gastric by-pass Body composition Nutrition Physical activity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013