Improving Diabetes After Bariatric Surgery

NCT00676923 | Completed DMC

• 2 other identifiers: DK6657_3bU01DK066557
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

Conditions

Obesity; Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.

You may qualify if:

• Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
• Enrollment in LABS-1 or LABS-2.
• Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
• Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
• Adequate IV access.

You may not qualify if:

• Informed consent not obtained.
• Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
• Creatinine greater than 1.7.
• Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
• Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).

Sponsors & Collaborators

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

Study Sites (5)

Legacy Good Samaritan Hospital

Portland, Oregon, United States

Location

Oregon Health and Science University

Portland, Oregon, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98195, United States

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jonathan Purnell, MD

  Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (5)