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ObesityELDSURGNCT02307942

Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years

A study testing Gastric banding in people with Obesity, run by University Hospital, Toulouse at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study is to compare the efficacy of two weight losing strategies (obesity surgery with gastric banding, and standard of care) on physical performance in elderly obese persons submitted to a physical training. Read more about this study

Who is it for?
Ages 60 to 75 years
Conditions the study is for
Obesity
What is being tested?
Gastric banding
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
7 sitesFrance
Study dates
29 Jul 2015to 4 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Criteria specific to the study Subjects aged 60 or over and younger than 75 yrs., seeking obesity treatments, seeking obesity surgery, with a BMI of 30 kg/m² or more, with comorbidities (see below), and a mildly decreased physical performance (SPPB between 5 and 8) are considered to participate in the study Criteria specific to obesity surgery This projects extends the classical recommendation for obesity surgery to people with a BMI of 30 and over with either the comorbidities list below, or a SPPB between 5 and 8. This level of physical impairment can be considered as a comorbidity in the elderly.
  • The French Ministry of health (HAS) recommends that obesity surgery be considered (here with a gastric banding) in patients fulfilling the following criteria:
  • Subjects with a BMI of 40kg/m² or more, or 35kg/m² or more if at least one comorbidity that can be improved by weight loss is present among hypertension, obstructive sleep apnea, severe metabolic disorder (such as type 2 diabetes, NASH), or rheumatologic conditions associated with disability.
  • After the failure of well designed medical, dietetic, psychological intervention followed up for 6-12 months, with no sufficient weight loss or in case of the failure of maintaining weight loss
  • In subjects well informed of the consequences of surgery, and after a multi-disciplinary evaluation
  • Subjects have understood and accepted the need for a long term medical and surgical follow up
Show all 9Show fewer
  • The risk of surgery is acceptable
  • patient who signed the informed consent
  • patient affiliated to a social security cover or equivalent

Who cannot join

  • Criteria specific to the study
  • These are the impossibility to follow a physical training (unstable coronary heart disease, severe lung function impairment, rheumatologic conditions preventing training, a SPPB score below 5, cancer treatment within the 3 last months, Parkinson's disease, other severe illness that may interfere with physical activity) Criteria specific to gastric banding
  • Cognitive impairment (MMSE ≤ 25)
  • Severe eating disorder
  • Impossible long-term follow-up
  • Alcohol or drug dependence
Show all 12Show fewer
  • Lack of previous well designed obesity care
  • Vital prognosis engaged in the short term
  • Contra-indications to anaesthesia Classical criteria for the non inclusion in a trial
  • The subject is in jail, or has freedom restriction
  • Guardianship curators or judicial protection
  • Patients participating in another intervention study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • Clinique de l'ANJOU

    Angers, 49000

  • Hôpital louis Mourier

    Colombes, 92701

  • CHU de LILLE

    Lille, 59000

  • Hospices Civils de LYON

    Lyon, 69495

  • CHU de Nantes

    Nantes, 44093

  • HEGP

    Paris, 75015

  • CHU de Toulouse

    Toulouse, 31059

Other trials in France

About this study

Official title: Does Intense Weight Loss Improve Physical Performance in Obese Patients Older Than 60 Yrs Undergoing Exercise Training? Comparison Between Surgery and Standard of Care.

The main objective of this study is to compare the efficacy of two weight losing strategies (obesity surgery with gastric banding, and standard of care) on physical performance in elderly obese persons submitted to a physical training. Our hypothesis is that a surgery-induced weight loss in the context of a physical training (which is recommended in people 60-75 yrs losing weight) improves physical performance as compared to standard of care (3-5% weight loss).

Read the detailed description

Randomized clinical trial; Single Blind A physical training is recommended in people above 60 yrs. engaged in a weight-losing program, in order to prevent the impairment of physical performance. Therefore a physical training program (endurance and strength training) will be implemented for all subjects participating in the study, starting 1 month before randomization. It will last for 13 months. Patients will be randomized either in the surgical group (gastric banding under general anesthesia) or in the reference group (mild calorie restriction and coaching). Physical performance of patients is evaluated at screening, inclusion, at randomization, 6 and 12 months after randomization.

Conditions
Obesity
Being tested
Gastric banding
Keywords
Randomized Clinical Trials, gastric banding, calorie restriction, SPPB, physical performance, elderly
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastric bandingProcedure or surgery

    The bariatric procedure is a gastric banding under general anesthesia with all the centres using the same surgical procedure (harmonized by group meetings). The laparoscopic surgical procedure has been described. The ERAS protocol will be applied in each centre. The inflation of the band will follow the procedures described by 0'Brien. The patients will attend a group education session before surgery, during which the eating behaviour with a band will be explained and practiced. Then after surgery, the routine procedure is applied.

Study groups in NCT02307942
Study groupRoleWhat they receive
SURGERYExperimentalPatient will be operated for a gastric banding disposal
Receives: Procedure: Gastric banding
STANDARDNo interventionStandard of care for obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical performance

    Short Physical Performance Battery score (SPPB)

    Measured: 12 months, comparing to the 6 months assesment

Secondary outcomes (10)

  1. Physical performance

    the components of the SPPB score

    Measured: At randomization, 6 and 12 months later

  2. weight loss

    kg, and % of initial weight

    Measured: At randomization, 6 and 12 months later

  3. Composition of weight loss

    % of weight lost as lean mass, as fat mass, changes in appendicular skeletal muscle mass

    Measured: At randomization, 6 and 12 months later

  4. Changes in muscle strength

    strain gauge

    Measured: At randomization, 6 and 12 months later

  5. Changes in aerobic fitness

    maximal aerobic capacity

    Measured: At randomization, 6 and 12 months later

  6. Early complications

    in operated patients : number of hospital re-admissions, number of deep venous thrombosis, number of pulmonary embolism, food intake (calories, protein, eating difficulties

    Measured: At randomization, 6 and 12 months later

  7. Calorie and protein intake

    dietary survey

    Measured: At randomization, 6 and 12 months later

  8. Quality of life score

    Nottingham quality of life score

    Measured: At randomization, 6 and 12 months later

  9. Disability

    Functional Status Questionnaire score

    Measured: At randomization, 6 and 12 months later

  10. Cognitive function

    MMSE

    Measured: At randomization, 6 and 12 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study start29 Jul 2015
  3. Primary completion4 Dec 2019
  4. Study completion4 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02307942
Sponsor's protocol ID
13 7051 01
Other IDs
13705101
Acronym
ELDSURG
Status last verified
Aug 2024
First submitted
16 Sep 2014
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.

    PubMed 15479938

  • Chevallier JM, Zinzindohoue F, Douard R, Blanche JP, Berta JL, Altman JJ, Cugnenc PH. Complications after laparoscopic adjustable gastric banding for morbid obesity: experience with 1,000 patients over 7 years. Obes Surg. 2004 Mar;14(3):407-14. doi: 10.1381/096089204322917954.

    PubMed 15072664

  • O'Brien PE, MacDonald L, Anderson M, Brennan L, Brown WA. Long-term outcomes after bariatric surgery: fifteen-year follow-up of adjustable gastric banding and a systematic review of the bariatric surgical literature. Ann Surg. 2013 Jan;257(1):87-94. doi: 10.1097/SLA.0b013e31827b6c02.

    PubMed 23235396

  • Mittermair RP, Obermuller S, Perathoner A, Sieb M, Aigner F, Margreiter R. Results and complications after Swedish adjustable gastric banding-10 years experience. Obes Surg. 2009 Dec;19(12):1636-41. doi: 10.1007/s11695-009-9967-7.

    PubMed 19763708

  • Chevallier JM, Paita M, Rodde-Dunet MH, Marty M, Nogues F, Slim K, Basdevant A. Predictive factors of outcome after gastric banding: a nationwide survey on the role of center activity and patients' behavior. Ann Surg. 2007 Dec;246(6):1034-9. doi: 10.1097/SLA.0b013e31813e8a56.

    PubMed 18043107

  • Gagner M, Milone L, Yung E, Broseus A, Gumbs AA. Causes of early mortality after laparoscopic adjustable gastric banding. J Am Coll Surg. 2008 Apr;206(4):664-9. doi: 10.1016/j.jamcollsurg.2007.11.014. Epub 2008 Jan 28.

    PubMed 18387472

Questions about this trial

What is this clinical trial studying?

A study testing Gastric banding in people with Obesity, run by University Hospital, Toulouse at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical performance (time frame: 12 months, comparing to the 6 months assesment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02307942, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.

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