NCT02333903

Brief Summary

This study compares the ratio of lean mass losses over total body mass losses between patients undergoing sleeve gastrectomy followed by physical activity training versus patients undergoing sleeve gastrectomy only

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 28, 2015

Status Verified

January 1, 2015

Enrollment Period

2.2 years

First QC Date

December 29, 2014

Last Update Submit

July 27, 2015

Conditions

Obesity

Keywords

ObesitySleeve gastrectomyPersonalized physical activity programBody CompositionFat massLean mass

Outcome Measures

Primary Outcomes (1)

  • Change in the ratio of lean mass losses over total body mass losses

    Percentage of lean mass loss compared to total body weight loss measured with bioimpedancemetry and dual energy X-Rays absorptiometry (DXA) at 1, 6 and 12 months after surgery

    1 month, 6 months, 12 months after surgery

Secondary Outcomes (18)

  • Changes in systolic blood pressure

    1 month, 3 months, 6 months, 9 months and 12 months after surgery

  • Change in the Body Mass Index (BMI)

    1 month, 3 months, 6 months, 9 months and 12 months after surgery

  • Changes in the lipid profile

    1 month, 3 months, 6 months, 9 months and 12 months after surgery

  • Changes of glycemia values

    1 month, 3 months, 6 months, 9 months and 12 months after surgery

  • Changes of HbA1C values

    1 month, 3 months, 6 months, 9 months and 12 months after surgery

  • +13 more secondary outcomes

Study Arms (2)

Personalized Physical Activity

EXPERIMENTAL

Patients will undergo a personalized physical activity program after sleeve gastrectomy.

Other: Personalized Physical Activity

Regular Activity

NO INTERVENTION

Patients will have regular physical activity after sleeve gastrectomy.

Interventions

Personalized Physical ActivityOTHER

1.5 hours physical training sessions, twice a week for 1 year, under the supervision of a dedicated coach specialized in supporting overweighted patients. Typical training session organized for small groups (5 patients) will consist of aerobic exercises, muscular strengthening (4 peripheral members and abdominal muscular belt), followed by stretching exercises.

Personalized Physical Activity

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \>40 kg/m² or BMI\>35kg/m² with comorbidities qualifying for bariatric surgery
  • Stable obesity or obesity evolving for more than 5 years
  • Patient cleared by the surgeon for sleeve gastrectomy one month before recruitment
  • Absence of contraindication for a sub-maximal stress test
  • Performance of a polysomnography before surgery
  • Signed informed consent
  • Patient benefiting from Health Care Coverage

You may not qualify if:

  • Absence of preliminary and regular medical check-ups mandatory before sleeve gastrectomy
  • Anticipated difficulty for patient follow-up
  • Mental diseases (psychosis, depression, suicidal behavior or history)
  • Eating disorders
  • Lack of informed consent or cooperation
  • Unsufficient patient commitment
  • Patient under judiciary protection
  • Patient not able to comply with any or all the research procedures over time including physical activity
  • Patient excluded from the french database of volunteers for clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Philibert

Lomme, 59462, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine Cracco, MD

    Groupement des Hôpitaux de l'Institut Catholique de Lille

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

January 7, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

July 1, 2017

Last Updated

July 28, 2015

Record last verified: 2015-01

Locations

FR(1)