N/A
Completed N=22
Diabetes and Gastric By- Pass
Source: ClinicalTrials.gov NCT01153516 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery — 61647.0; 59476.1 mg/dL*min
Summary
The purpose of this study is to evaluate the mechanisms leading to rapid postoperative improvement in diabetes following Gastric By-Pass surgery for obesity.We will evaluate and compare the changes in glucose level, beta-cell function, and insulin resistance induced by a week of very low calorie liquid diet and those induced by a week of matched very -low calorie liquid diet occuring in the context of routine postoperative care following RYGB.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response in Glucose AUC at Baseline vs. Following Gastric Bypass Surgery |
61647.0; 59476.1 | — |
| PRIMARY Response in Insulin AUC at Baseline vs Following Gastric Bypass Surgery |
7888.6; 4259.3 | — |
| PRIMARY Response in Glucagon AUC at Baseline vs. Following Gastric Bypass |
24332.8; 32929.1 | — |
Eligibility Criteria
Inclusion Criteria
- volunteers that are planned to undergo RYGB(Roux-en-Y By pass) and have type 2 diabetes diagnosed within the prior 10 years.
Exclusion Criteria
- abnormal renal function
- significant anemia
- difficult venous access
- treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
- recent change in use of any pharmacologic agent with potential effect on either beta-cell function or insulin resistance.
- pregnancy
- non -English speakers
Data sourced from ClinicalTrials.gov (NCT01153516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.