Diabetes Mellitus Typ 2 and Obesity Clinical Trial
Official title:
Mechanisms Behind Antidiabetic Effects by Gastric By-pass
| Verified date | March 2014 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: The National Board of Health and Welfare |
| Study type | Interventional |
The aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Diabetes typ 2 - 18-70 years - BMI > 35 kg/m2 - Treated with oral antidiabetic agents and/or insulin - laparoscopic surgery Exclusion Criteria: - Pharmacological treatment (other then above) witch could affect glucose metabolism - open surgery |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institutet | Stockholm | Stockholm County Council |
| Sweden | Uppsala University Hospital | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Uppsala University Hospital |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Insulin signaling and glucose transport in skeletal muscle | 12-18 month after gastric by-pass | No | |
| Primary | Insulin sensitivity | Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique | 12-18 month after gastric bypass | No |
| Secondary | Weight reduction | 12-18 month after gastric bypass | No |