Type 2 Diabetes MellitusNCT01323114
The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study
A study testing Laparoscopic duodenal exclusion and Conventional Medical Treatment in people with Type 2 Diabetes Mellitus, run by McKenzie Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Laparoscopic duodenal exclusion and Conventional Medical Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
McKenzie Health System
Sandusky, Michigan, 48471
Marcus K Free, M.D., 810-648-9707, drfree@mckenziehealth.org
Steve Barnett, M.S., 810-648-3770
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Laparoscopic duodenal exclusion, Conventional Medical Treatment
- Keywords
- type 2 diabetes mellitus, non-morbidly obese, laparoscopic duodenal exclusion
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic duodenal exclusionProcedure or surgery
Also called duodenal exclusion, duodenal bypass
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 TreatmentOther
Also called control arm
Standard of care medical treatment for type 2 diabetes to include medications and dietary management under the monitoring of the study endocrinologist.
| Study group | Role | What they receive |
|---|---|---|
| Medical Control Group | Active comparator | 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. Receives: Other: Conventional Medical Treatment |
| Surgical Treatment Group | Experimental | 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. Receives: Procedure: Laparoscopic duodenal exclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
The primary outcome is the difference in hemoglobin A1C between the surgical treatment arm and the conventional medical treatment arm.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McKenzie Health System
- Sponsor type
- University, hospital or other
- Investigators
- Marcus K. Free, M.D., Principal investigator, McKenzie Health SystemSteve Barnett, M.S., Study director, McKenzie Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323114
- Sponsor's protocol ID
- LDE-199979-1
- Status last verified
- Mar 2011
- First submitted
- 24 Mar 2011
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Treatment of Type 2 Diabetes Mellitus in Non-Morbidly Obese Patients: A Community Hospital Study
- ClinicalTrials.gov ID
- NCT01323114
- Acronym / sponsor ID
- LDE-199979-1
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, non-morbidly obese, laparoscopic duodenal exclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- McKenzie Health SystemUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 25 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Control Group | Active comparator | Other: Conventional Medical TreatmentControl 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 | Experimental | Procedure: Laparoscopic duodenal exclusionExperimental 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic duodenal exclusionAlso: duodenal exclusion, duodenal bypassLaparoscopically-performed Roux-en Y intestinal bypass of the duodenum and proximal jejunum; stomach remains normal size and proximal division performed just distal to pylorus. | Procedure or surgery | Surgical Treatment Group |
| Conventional Medical TreatmentAlso: control armStandard of care medical treatment for type 2 diabetes to include medications and dietary management under the monitoring of the study endocrinologist. | Other | Medical Control Group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus K. Free, M.D. principal investigator
McKenzie Health System
Steve Barnett, M.S. study director
McKenzie Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic duodenal exclusion and Conventional Medical Treatment in people with Type 2 Diabetes Mellitus, run by McKenzie Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus K Free, M.D. (810-648-9707, drfree@mckenziehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2011.