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NCT02710786 Clinical Trial

Comorbidity After Gastric Bypass

Severe Obesity Clinical Trial

Official title:
Long-term Resolution of Comorbidites After Gastric Bypass

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02710786
Other study ID # Comorb
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2007
Est. completion date January 2025

Study information
Verified date December 2023
Source Uppsala University
Contact Erik Näslund
Email erik.naslund@ki.se
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To evaluate effect on comorbid disease and weight loss in the long-term (>five years) after Roux-en-Y gastric bypass (RYGB) surgery for severe obesity.

Description:

Individuals with severe obesity frequently have comorbid diseases, e.g. diabetes, hypertension, hyperlipidemia, and sleep apnea. We will study the remission rate and weight loss in the long-term (10 years) after Roux-en-Y gastric bypass (RYGB) surgery in a nationwide large group of patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 25000
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Registered individuals in Scandinavian Obesity Surgery Registry (SOReg) having had gastric bypass Exclusion Criteria: - All other operations

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Gastric bypass
Gastric bypass surgery, i.e., small gastric pouch and excluded main stomach

Locations
Country Name City State
Sweden Uppsala University Uppsala

Sponsors (3)
Lead Sponsor Collaborator
Uppsala University Karolinska Institutet, The Scandinavian Obesity Surgery Registry

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in comorbid conditions, as defined by use of pharmacological treatment Remission of diabetes mellitus, hypertension, dyslipidemia, and depression as defined by use of pharmacological treatment, and sleep apnea as defined by use of CPAP. Data will be collected from SOReg. 10 years
Secondary Number of patients with pathological laboratory data (corresponding to the studied comorbid conditions) Glucose, HbA1c, LDL, HDL, triglycerides, and blood pressure 10 years
Secondary Weight loss Peroperative weight (in kg) minus current weight (in kg) 10 years
Secondary BMI loss Peroperative BMI minus current BMI. Weight and height will be combined to report BMI in kg/m^2. 10 years
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