Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

Morbid Obesity Clinical Trial

Official title:

Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239850
• Other study ID #: 4.2005.33
• Secondary ID: NSD1282005/3344T
• Status: Completed
• Phase: N/A
• First received: October 13, 2005
• Last updated: March 21, 2017
• Start date: August 2005
• Est. completion date: August 2007

Study information

• Verified date: March 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).

Description:

The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass. Two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic. Sixty patients will participate in each group. Behavioural changes and weight loss over 4-5 years will be followed. We will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: August 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) > 40 or BMI > 35 with complications

Exclusion Criteria:

• Unstable atherosclerotic disease

• Psychologically unstable

• Unable to participate in the training program

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Behavioral:
• lifestyle changes

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Martins C, Strømmen M, Stavne OA, Nossum R, Mårvik R, Kulseng B. Bariatric surgery versus lifestyle interventions for morbid obesity--changes in body weight, risk factors and comorbidities at 1 year. Obes Surg. 2011 Jul;21(7):841-9. doi: 10.1007/s11695-01 — View Citation

Øvrebø B, Strømmen M, Kulseng B, Martins C. Bariatric surgery versus lifestyle interventions for severe obesity: 5-year changes in body weight, risk factors and comorbidities. Clin Obes. 2017 Mar 20. doi: 10.1111/cob.12190. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight reduction
Primary	quality of life
Secondary	reduction in obesity complications