The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 20 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | April 2011 |
| End Date: | May 2014 |
| Contact: | Marcus K Free, M.D. |
| Email: | drfree@mckenziehealth.org |
| Phone: | 810-648-9707 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
