Mechanisms of Glycemic Improvement After Gastrointestinal Surgery

NCT01025999 | Completed DMC

• 2 other identifiers: 36417-A1R01DK084324-01
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type II

Keywords

RYGB; Gastrostomy tube; DM; Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• 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.

  1/2010 - 6/2014

Secondary Outcomes (1)

• To evaluate whether improvements in glucose control occurring early after RYGB are related to altered insulin secretion, insulin sensitivity, or both.

  1/2010-6/2014

Study Arms (1)

RYGB

UWMC patients undergoing RYGB surgery with routine placement of Gastrostomy tube.

Other: No intervention

Interventions

No intervention OTHER

RYGB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planning to undergo RYGB at UWMC with planned placement of gastrostomy tube.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma collected to measure markers of metabolic activity.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David R Flum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• David E Cummings, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

US (1)