Early Diabetes Resolution After Weight Loss Surgery

Obesity Clinical Trial

Official title:

Hormonal and Inflammatory Parameters Affecting Early Diabetes Resolution Following Weight Loss Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790309
• Other study ID #: NNA-Early DM Resolution
• Status: Completed
• Phase: N/A
• First received: November 11, 2008
• Last updated: April 20, 2017
• Start date: December 2008
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective is to compare inflammatory, hormonal, and metabolic changes in the very short term after various bariatric surgical procedures (Roux-en Y Gastric Bypass, Vertical Sleeve Gastrectomy, and Adjustable Gastric Banding)and other abdominal surgeries, as well as to compare these changes to diet-induced changes in the same population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for surgery groups:

• BMI of 30 kg/m2 or higher

• Ages 18-65

• History of impaired glucose tolerance or T2DM

Inclusion Criteria for normal weight group:

• BMI of 30 kg/m2 or lower

• Ages 18-65

Exclusion Criteria:

• Development of an intercurrent infection

• Prior gastric, duodenal, proximal jejunal surgery or pancreas resection

• Current use of thiazolidinediones

• Current use of dipeptidyl peptidase-IV inhibitors (e.g., sitagliptin) or glucagon-like peptide-1 analogs (e.g., exenatide)

• Any condition felt by the PI or co-investigators to interfere with ability to complete the study

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Obesity
• Weight Loss

Intervention

Procedure:
• Weight loss surgery
Weight loss surgery
• Laparoscopic abdominal surgeries
laparoscopic abdominal surgeries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine to what extent improvements in glycemic control can be attributed to caloric restriction after weight loss surgery		10 days post-op
Secondary	Determine changes in inflammatory markers after weight loss surgery		10 days post-op