Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy

Obesity Clinical Trial

Official title:

Study of Incretins Response and Glycemic Control: Pre Diet, After Conventional Weight Loss and in the Early Postoperative Phase After Gastric Bypass in T2D-patients.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01820273
• Other study ID #: MRD-Study
• Status: Withdrawn
• Start date: April 2013
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2019
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2019
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of type 2 diabetes

• obesity BMI >35

Exclusion Criteria:

• prior bariatric surgery

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Locations

Country	Name	City	State
Sweden	Kalmar County Hospital	Kalmar

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Kalmar County Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in incretines in the bariatric patient	standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.	2 months prior to surgery - 6 weeks post surgery
Secondary	Diabetes control	resolution of t2D as early as first day after surgery	6 weeks post surgery