Severe Obesity Clinical Trial
Official title:
Long-term Resolution of Comorbidites After Gastric Bypass
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Uppsala University | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Karolinska Institutet, The Scandinavian Obesity Surgery Registry |
Sweden,
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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