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

April 12, 2011 updated by: McKenzie Health System
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetes is a disease of glucose metabolism which in the United States in 2007 was estimated to effect at least 17.5 million people with type 2 diabetes mellitus accounting for approximately 90% to 95%. Poorly-controlled or treated type 2 diabetes is associated with a variety of health risks, including heart disease, stroke, renal failure, amputations,and blindness and is the seventh leading cause of death in the United States (NDIC, National Diabetes Statistics, 2011). A large number of medical treatments are available yet approximately 67% of patients in the United States with type 2 diabetes are unable to reach levels of hemoglobin A1C less than 6.5%, which is the target level set by the American Association of Clinical Endocrinologists (AACE, State of Diabetes in America, 2011). In patients with type 2 diabetes mellitus who are also morbidly obese, certain bariatric surgical procedures have shown improvement in the control of type 2 diabetes in addition to the expected weight loss effects. However, clinical investigations have pointed to a mechanism other than just weight loss in the improvement of type 2 diabetes in these patients and raised the possibility of utilizing the same mechanism in non-morbidly obese patients. Subsequent basic science research in 2004 involving a surgical bypass procedure of the proximal intestine in non-obese mice with type 2 diabetes mellitus showed remission of diabetes in the majority of mice and marked improvement over medical treatment in the remaining mice (13). Human clinical trials have been conducted in various locations worldwide and have produced similar results to the animal study; a call has been made for studies of new surgical procedures for the treatment of type 2 diabetes in IRB-approved clinical trials (39). In several studies, the duodenal exclusion, which is a procedure which bypasses the duodenum and proximal jejunum and leaves the stomach intact, has been shown to cause remission or marked improvement in type 2 diabetes mellitus without significant weight loss in non-morbidly obese patients. However, no study within the United States has compared the effect of this surgical procedure upon type 2 diabetes with the effect of conventional medical treatment of type 2 diabetes in a controlled clinical trial. In this clinical study, the investigators propose to directly compare the treatment of type 2 diabetes mellitus in non-morbidly obese humans by a surgical bypass of the duodenum and proximal jejunum to the treatment of a similar group of humans treated with conventional medical therapy. Our hypothesis is that a non-bariatric surgical procedure, the laparoscopic duodenal exclusion, will provide improved treatment of type 2 diabetes mellitus in non-morbidly obese patients when compared to conventional medical treatment. The measures of the treatment of type 2 diabetes mellitus in which a difference is expected to be observed are glycosylated hemoglobin A1C (HbA1C), fasting glucose, and insulin resistance. The investigators propose a prospective, controlled, non-randomized clinical trial to test this hypothesis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Sandusky, Michigan, United States, 48471
        • Recruiting
        • McKenzie Health System
        • Contact:
        • Contact:
          • Steve Barnett, M.S.
          • Phone Number: 810-648-3770

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Other Names:
  • control arm
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.
Procedure: 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.
Other Names:
  • duodenal exclusion
  • duodenal bypass

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: One year
The primary outcome is the difference in hemoglobin A1C between the surgical treatment arm and the conventional medical treatment arm.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McKenzie Health System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcus K. Free, M.D., McKenzie Health System
  • Study Director: Steve Barnett, M.S., McKenzie Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LDE-199979-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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