Treatment of Type 2 Diabetes Mellitus by Duodenal Exclusion Associated With Omentectomy: Clinical… (NCT00566215) | Clinical Trial Compass
TerminatedPhase 1/2
Treatment of Type 2 Diabetes Mellitus by Duodenal Exclusion Associated With Omentectomy: Clinical and Hormonal Study
Stopped: Benefit of duodenal exclusion alone less than expected for treatment of type 2 diabetes; an additional effect of combination with omentectomy not observed
Brazil6 participantsStarted 2007-07
Plain-language summary
Based in a surgery technique studied in a non-obese diabetic mouse model by Rubino and Marescaux(2004), wich reversed diabetes in those animals, we have performed a previous study in human volunteers with type 2 diabetes and overweight (non-obese). The surgery is a duodenal exclusion in wich the stomach volume is kept intact. We observed improvement of glycemic control and hemoglobin A1c, allied to reduction of medicines: insulin was withdrawn or significantly lowered.
Further improvement of diabetes could be achieved by intervention in insulin resistance, another factor of diabetes pathophysiology. As that factor is related to visceral fat, we hypothesize that surgical removal of the major omentum, a great component of central adiposity, could beneficial .
This study will evaluate the mechanisms of amelioration of type 2 diabetes mellitus after duodenal exclusion surgery plus total omentectomy, by the method of standardized meal stimulus and insulin tolerance test, in human non-obese volunteers with diabetes type 2 and known insulin secretion capacity.
The previously studied volunteers submitted to duodenal exclusion without omentectomy will be the control group.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: 18 to 60 years.
* BMI between 25 and 29,9 kg/m².
* Weight variance less than 5% in the last 3 months.
* Previous diagnosis of diabetes type 2.
* Insulin requirement, alone or along with oral agents
* Capacity to understand the procedures of the study.
* To agree voluntarily to participate of the study, signing an informed consent.
Exclusion Criteria:
* Positive Anti-GAD antibodies
* Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
* History of hepatic disease like cirrhosis or chronic active hepatitis.
* Kidney dysfunction (creatinine \> 1,4 mg/dl in women and \> 1,5 mg/dl in men).
* Hepatic dysfunction: ALT and/or AST 3x above upper normal limit.
* Recent history of neoplasia (\< 5 years).
* Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — do you know why it was stopped, and does that affect whether the approach of duodenal exclusion combined with omentectomy is still considered safe or promising for someone in my situation?
2Since this was a Phase 1/2 trial combining two surgical procedures — duodenal exclusion and omentectomy — what is known so far about the safety profile of doing both surgeries together, especially for someone with Type 2 diabetes and insulin resistance?
3Given that this trial was testing whether these surgeries could improve or even reverse Type 2 diabetes, are there other completed or ongoing studies looking at similar surgical approaches that might be worth considering instead?
4For a patient with my level of obesity and insulin resistance, would you recommend exploring a surgical route like this at all, or is optimizing medications and lifestyle changes still the better first step given how early this research is?
5Because this trial was terminated, is there any published data from it that you've reviewed, and does what was learned change how you think about surgical options for managing my diabetes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement or reversal of type 2 diabetes mellitus
Timeframe: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year