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Procedure

The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study

N/A
Waitlist Available
Led By Marcus K. Free, M.D.
Research Sponsored by McKenzie Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

Type 2 diabetes mellitus is a chronic disease with severe long-term health consequences. In patients with type 2 diabetes mellitus who are also morbidly obese, an abundance of clinical evidence exists showing that significant clinical improvement in their diabetes occurs following certain types of bariatric, or weight loss, surgical procedures. There is additional data showing that bariatric surgical procedures that bypass the beginning of the small intestine, such as the Roux-en Y gastric bypass, can markedly improve type 2 diabetes even before significant weight loss has occurred. This early effect on type 2 diabetes prior to weight loss suggests that bypassing the beginning of the small intestine in patients who are not morbidly obese may also treat type 2 diabetes. There have been small studies outside the United States that support the concept of treating type 2 diabetes with a surgical procedure that bypasses the beginning of the small intestine without causing significant weight loss; however, data is limited in the United States and a call for comparative studies has been made internationally. The investigators propose to compare, in patients who are not morbidly obese, conventional medical treatment of type 2 diabetes to surgical treatment of type 2 diabetes using a bypass procedure that does not cause significant weight loss, the laparoscopic duodenal exclusion.

Eligible Conditions
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemoglobin A1C

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgical Treatment GroupExperimental Treatment1 Intervention
Experimental group in which patients will undergo the laparoscopic duodenal bypass procedure along with regular dietary and diabetic education, under the monitoring of the study endocrinologist.
Group II: Medical Control GroupActive Control1 Intervention
Control group of patients who will receive conventional medical treatment for type 2 diabetes, along with regular dietary and diabetic education, under the monitoring of the study endocrinologist.

Find a Location

Who is running the clinical trial?

McKenzie Health SystemLead Sponsor
Steve Barnett, M.S.Study DirectorMcKenzie Health System
Marcus K. Free, M.D.Principal InvestigatorMcKenzie Health System
~4 spots leftby Dec 2025