Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mechanisms of Glycemic Improvement After Gastrointestinal Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Skye Steptoe, University of Washington
ClinicalTrials.gov Identifier:
NCT01025999
First received: December 2, 2009
Last updated: March 19, 2014
Last verified: March 2014

December 2, 2009
March 19, 2014
January 2010
June 2015   (final data collection date for primary outcome measure)
Determine if the improvements in glycemic control occurring early after RYGB can be reversibly inactivated and activated through delivery or exclusion of nutrients in the bypassed proximal small intestine. [ Time Frame: 1/2010 - 6/2014 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01025999 on ClinicalTrials.gov Archive Site
To evaluate whether improvements in glucose control occurring early after RYGB are related to altered insulin secretion, insulin sensitivity, or both. [ Time Frame: 1/2010-6/2014 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mechanisms of Glycemic Improvement After Gastrointestinal Surgery
Mechanisms of Glycemic Improvement After Gastrointestinal Surgery

This study is designed as a prospective clinical trial aimed at investigating the mechanisms behind observed improvements in type 2 diabetes mellitus (T2DM) following bariatric surgery. The majority of patients with T2DM who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, in particular, experience complete remission of T2DM almost immediately post-surgery. This response occurs before significant weight loss is possible. To assess the mechanisms involved with disease resolution, the investigators propose a study to evaluate patients at the UW Medical Center (UWMC) who have T2DM and are undergoing RYGB with G (gastronomy)-tube placement as part of their clinical care. The investigators are interested in this sub-population as the G-tube allows us the unique opportunity to evaluate glycemic control and insulin response following delivery or exclusion of nutrients to the otherwise bypassed portion of the gastrointestinal tract. The investigators hypothesize that nutrient delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved in glucose control.

Roux-en-Y gastric bypass surgery causes complete, durable remission of type 2 diabetes (T2DM) in 84% of cases, typically within a few days to weeks after surgery. Mounting evidence indicates that this dramatic phenomenon results from effects beyond those related to weight loss and reduced caloric intake alone. The mechanisms mediating the weight-independent anti-diabetes impact of RYGB are unknown, and elucidating them could lead to new diabetes medicines. Human subjects will undergo frequently sampled I.V. glucose tolerance tests (FS-IVGTT) and tracer-enhanced hyperinsulinemic/euglycemic clamps (to measure insulin secretion and sensitivity) before RYBG and 3 times in the first six weeks afterward, during which the proximal small bowel will either be excluded from nutrient contact or exposed to nutrients delivered through an indwelling gastric cannula. We hypothesize that nutrient delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved in glucose control. Our study will allow us to test the upper intestinal hypothesis rigorously in man, and whether the hypothesis is confirmed or refuted, we will gain valuable new insights into the mechanisms of improved glucose control early after RYGB.

Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Diabetes Mellitus, Type II
Other: Metabolic Testing
Four overnight metabolic testing sessions. Each session includes a Meal Tolerance Test and an IV Glucose Tolerance Test with Hyperglycemic/Euglycemic Clamp.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years or greater and planning to undergo RYGB at UWMC
  • Ability to speak English and communicate effectively with research staff
  • Ability to return for follow-up visits at UWMC
  • Adequate IV access
  • A G-tube is planned as part of the bariatric surgical procedure
  • Documented T2DM (fasting plasma glucose >125 mg/dL) that is treated with lifestyle efforts or by taking acceptable oral medications

Exclusion Criteria:

  • Informed consent not obtained
  • Unlikely to comply with the protocol
  • Current HbA1c >8.5% or fasting blood glucose >180 mg/dL
  • Serum creatinine >1.7 mg/dL
  • Use of unacceptable diabetes medications at baseline
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01025999
36417-A, 1R01DK084324-01
Yes
Skye Steptoe, University of Washington
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: David R Flum, MD, MPH University of Washington
Principal Investigator: David E Cummings, MD University of Washington
University of Washington
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP