The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes-mellitus
Started Apr 2011
Typical duration for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 25, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 13, 2011
March 1, 2011
3.1 years
March 24, 2011
April 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1C
The primary outcome is the difference in hemoglobin A1C between the surgical treatment arm and the conventional medical treatment arm.
One year
Study Arms (2)
Medical Control Group
ACTIVE COMPARATORControl 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.
Surgical Treatment Group
EXPERIMENTALExperimental 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
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.
Standard of care medical treatment for type 2 diabetes to include medications and dietary management under the monitoring of the study endocrinologist.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McKenzie Health System
Sandusky, Michigan, 48471, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus K. Free, M.D.
McKenzie Health System
- STUDY DIRECTOR
Steve Barnett, M.S.
McKenzie Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 25, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 13, 2011
Record last verified: 2011-03