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:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01113996
First received: April 29, 2010
Last updated: November 21, 2013
Last verified: October 2012
  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: December 2014
Estimated Primary Completion Date: December 2014 (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: November 21, 2013
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 April 17, 2014