Recruiting

Surgical Treatment

Sponsor:

McKenzie Health System

Code:

NCT01323114

Conditions

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Laparoscopic duodenal exclusion

Conventional Medical Treatment

Study Details

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Study ID

NCT01323114

Start date

Apr, 2011

Status verified date

Mar, 2011

Completion date

May, 2014

Anticipated

Primary completion date

May, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosis of type 2 diabetes mellitus
  • fasting blood glucose > 126 mg/dl
  • on hypoglycemic medications for the treatment of type 2 diabetes
  • inadequate control of diabetes with glycosylated hemoglobin A1c > 7.5
  • body mass index between 20 and 35
  • C-peptide level 1.0 mg/dl or higher
  • ability to understand the proposed surgical treatment and its mechanism
  • ability to understand the risks and benefits of the proposed surgery
  • ability to commit to the study requirements for followup and education
  • ability to give properly informed consent for participation

Exclusion Criteria:

  • body mass index 35 or higher, or less than 20
  • previous diagnosis of type 1 diabetes mellitus or mixed diabetes
  • pregnancy, within one year postpartum, or currently breastfeeding
  • recent (within 1 year) gastric or duodenal ulcer
  • use of immunosuppressive medications or known immunosuppressive disorder
  • previous gastric, duodenal, or small intestinal surgery
  • inflammatory bowel disease
  • treatment with anticoagulant or antiplatelet medication other than aspirin 81 mg/day
  • end-stage renal disease or on dialysis
  • any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to participate in the study

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medical Control Group

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.

experimental: Surgical Treatment Group

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.

Interventions

Laparoscopic duodenal exclusion

Laparoscopically-performed Roux-en Y intestinal bypass of the duodenum and proximal jejunum; stomach remains normal size and proximal division performed just distal to pylorus.

Conventional Medical Treatment

Standard of care medical treatment for type 2 diabetes to include medications and dietary management under the monitoring of the study endocrinologist.

Primary outcome measure

  • Hemoglobin A1C [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Locations

McKenzie Health System

Recruiting

Sandusky, Michigan, United States, 48471

Contacts

Steve Barnett, M.S.

810-648-3770

More Information

Sponsor

McKenzie Health System

Last update posted

Apr 13, 2011

Last verified

Mar, 2011

Keywords

  • type 2 diabetes mellitus
  • non-morbidly obese
  • laparoscopic duodenal exclusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McKenzie Health System on 2011-04-13.