Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2017
Date assigned
15/03/2017
Last edited
15/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
As obesity is becoming more common worldwide, more people are undergoing weight-loss surgery such as primary laparoscopic gastric bypass, where the digestive system is re-routed past most of the stomach so that less food is digested and it takes much less food to feel full. Weight-loss surgery often has good results on obesity and related diseases. Little is known, however, about what happens to muscle strength and the abdominal wall after weight-loss surgery. Previous studies have shown that thigh muscle strength is reduced after weight-loss surgery. The aim of this study is to collect information to see whether weight loss causes muscular strength problems that could have an effect on the decision to undergo surgery.

Who can participate?
Patients undergoing primary laparoscopic gastric bypass

What does the study involve?
Blood samples are taken to measure connective tissue and wound healing markers before surgery and 2 weeks, 1 month, 3 months and 6 months after surgery. Tissue samples of the abdominal wall are collected during surgery, and are also tested for connective tissue and wound healing markers. Muscle strength in the abdominal wall and thigh are measured once before and 6 months after surgery. Physical ability and abdominal wall function are also measured using questionnaires before and 6 months after surgery.

What are the possible benefits and risks of participating?
The muscle measurements are generally well tolerated and can heighten awareness of physical ability after surgery. The extra blood samples required in this study can be taken together with regular blood samples before and after surgery. The small (5 mm) tissue samples are not expected to be noticed in any way by the participants as these are taken during surgery.

Where is the study run from?
1. Lycksele Hospital (Sweden)
2. Uppsala University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
October 2015 to September 2019

Who is funding the study?
Umeå University (Sweden)

Who is the main contact?
Dr Jeff Wennerlund
Jeff.Wennerlund@umu.se

Trial website

http://clister.se/doktorander/jeffwennerlund.html

Contact information

Type

Public

Primary contact

Dr Jeff Wennerlund

ORCID ID

http://orcid.org/0000-0003-0603-751X

Contact details

Department of Surgery and Orthopedics
Lycksele Hospital
Lycksele
92182
Sweden
+46 (0)950 39124
Jeff.Wennerlund@umu.se

Type

Scientific

Additional contact

Prof Ulf Gunnarsson

ORCID ID

Contact details

Department of Surgery and Perioperative Sciences
Umeå University
Umeå
901 87
Sweden
+46 (0)90 7852909
Ulf.Gunnarsson@umu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GUMP

Study information

Scientific title

Does muscle strength and abdominal wall function improve with weight loss after gastric bypass? A clinical observational study

Acronym

GUMP

Study hypothesis

Research questions:
1. Does bariatric surgery improve abdominal wall function after weight loss?
2. Does weight loss after bariatric surgery cause problems with the abdominal wall?

Ethics approval

Regional Ethics Review Board, Umeå, 10/1/2016, ref: 2015/367-31

Study design

Clinical observational study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet (in Swedish only)

Condition

Obesity, weight loss, muscle strength

Intervention

Blood samples are collected to analyze matrix metalloproteinases before surgery, as well as 2 weeks, 1 month, 3 months and 6 months after. Abdominal wall muscle and fascia biopsies are collected during surgery for analysis of matrix metalloproteinases. Abdominal wall and thigh strength are measured with the use of BioDex System 3 before and 6 months after gastric bypass. Physical ability and abdominal wall function are also measured using Ventral Hernia Pain Questionnaire (VHPQ), International Physical Ability Questionnaire (IPAQ) and Visual Analog Scale for abdominal wall function (VAS), all once before and once 6 months after surgery.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Matrix metalloproteinases, measured from blood samples taken at baseline (pre-operatively) and 2 weeks, 1 month, 3 months and 6 months postoperatively
2. Abdominal wall and thigh muscle strength, measured with the BioDex System 3 at baseline (pre-operatively) and 6 months post-operatively
3. Physical ability and abdominal wall function, measured using the Ventral Hernia Pain Questionnaire (VHPQ), International Physical Activity Questionnaire (IPAQ), and Visual Analog Scale (VAS) for abdominal wall function at baseline (pre-operatively) and 6 months postoperatively

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/10/2015

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients eligible for primary laparoscopic gastric bypass
2. All patients undergoing primary laparoscopic gastric bypass at Lycksele Hospital are eligible for recruitment
3. Patients undergoing surgery in Uppsala are eligible for collection of blood and tissue samples only
4. All ages

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

50 in group with blood and tissue samples along with BioDex measurement and questionnaires. Another 50 with only blood and tissue samples, and questionnaires.

Participant exclusion criteria

If, after inclusion, no or different surgery is planned

Recruitment start date

30/09/2016

Recruitment end date

31/03/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Surgery, Västerbottens läns landsting (County Council)
Hedlundavägen Lycksele Hospital
Lycksele
92182
Sweden

Trial participating centre

Department of Surgery
Uppsala University Hospital
Uppsala
75185
Sweden

Sponsor information

Organisation

County Council of Västerbotten (Västerbottens läns landsting)

Sponsor details

Köksvägen 11
Umeå
90185
Sweden
+46 (0)90 7850000
landstinget@vll.se

Sponsor type

Government

Website

www.vll.se

Funders

Funder type

University/education

Funder name

Umeå Universitet

Alternative name(s)

Umeå University

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Results and Publications

Publication and dissemination plan

This study is expected to give rise to three publications:
1. The change in matrix metalloproteinases (MMPs) before and after gastric bypass
2. The change in abdominal muscle strength as related to the questionnaires and change in MMPs in both blood and tissue, as well as degree of weight loss
3. The change in thigh muscle strength in relation to the questionnaires and change in MMPs and body weight
The results are to be presented at national and international conferences. Publication is planned in peer-reviewed journals from the later half of 2019 until at least a year later, depending on the trial end date.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jeff Wennerlund (Jeff.Wennerlund@umu.se).

Intention to publish date

01/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes