Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy
Sponsor
Lund University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01820273
Collaborator
Kalmar County Hospital (Other)
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1
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Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Study Start Date
:
Apr 1, 2013
Actual Primary Completion Date
:
May 1, 2016
Actual Study Completion Date
:
Aug 1, 2019
Outcome Measures
Primary Outcome Measures
- changes in incretines in the bariatric patient [2 months prior to surgery - 6 weeks post surgery]
standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.
Secondary Outcome Measures
- Diabetes control [6 weeks post surgery]
resolution of t2D as early as first day after surgery
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
clinical diagnosis of type 2 diabetes
-
obesity BMI >35
Exclusion Criteria:
- prior bariatric surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kalmar County Hospital | Kalmar | Sweden | 39185 |
Sponsors and Collaborators
- Lund University
- Kalmar County Hospital
Investigators
- Study Director: Nils Wierup, Lunds Universitet, Clinical researchcenter
- Principal Investigator: Johan Berggren, MD, Lunds Universitet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lund University
ClinicalTrials.gov Identifier:
NCT01820273
Other Study ID Numbers:
- MRD-Study
First Posted:
Mar 28, 2013
Last Update Posted:
Aug 7, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Lund University
Additional relevant MeSH terms: