Monitoring Patients Who Are Obese Surgery for Gastric By-pass Protein Supplementation and Physical Training (PROMISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 13, 2014
Last verified: June 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 13, 2014
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 October 19, 2014