Diabetes MellitusNCT02949687
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
A study testing ileal interposition with sleeve and sympathectomy in people with Diabetes Mellitus and Obesity, run by Universidade Positivo.
Trial summary
Surgical Treatment in Diabetic Patients With Grade 1 Obesity Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- ileal interposition with sleeve and sympathectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2016to 1 Dec 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Documented diagnosis of type 2 diabetes mellitus
- Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors
- Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks
- HbA1c> 8.0%
- Age> 20 years and <60 years
- Body mass index (BMI) of 30 35 kg / m²
- Agree to sign the consent form
Who cannot join
- Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation <0.5 ng / ml)
- Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors
- Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months)
- Malignant neoplasm
- Portal hypertension
- Inability to cooperate with segment
Show all 12Show fewer
- Low capacity of understanding surgery
- Unrealistic expectations of the outcome
- Cognitive impairment
- Current pregnancy
- Moderate or severe mood disorder; severe anxiety; eating disorders (based on Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria)
- Chemical dependency or alcoholism (based on DSM-V criteria).
About this study
Official title: Duodenal Ileal Interposition With Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Read the detailed description
There will be a randomized clinical trial, non-blind, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus), including 40 research subjects with type 2 diabetes mellitus and obesity class I. In order to analise the effect on weight loss and glycemic control after 2 years of follow up
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- ileal interposition with sleeve and sympathectomy
- Keywords
- ileal interposition, metabolic surgery, diabetes, intra abdominal selective denervation
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileal interposition with sleeve and sympathectomyProcedure or surgery
laparoscopic ileal interposition with sleeve and sympathectomy
| Study group | Role | What they receive |
|---|---|---|
| ileal interposition sleeve sympathectomy | Experimental | laparoscopic ileal interposition with sleeve and sympathectomy Receives: Procedure: ileal interposition with sleeve and sympathectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications
Success Rate of Biochemical Resolution of Diabetes at 24 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start20 Sep 2016
- Primary completion1 Mar 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Positivo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciana El-Kadre, Universidade Positivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949687
- Sponsor's protocol ID
- CAAE 37048114.9.0000.0093
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2016
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duodenal Ileal Interposition With Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02949687
- Acronym / sponsor ID
- CAAE 37048114.9.0000.0093
- Conditions
- Diabetes Mellitus, Obesity
- Keywords
- ileal interposition, metabolic surgery, diabetes, intra abdominal selective denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidade PositivoUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 31 Oct 2016 (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.
Surgical Treatment in Diabetic Patients With Grade 1 Obesity
Detailed description
There will be a randomized clinical trial, non-blind, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy and Selective Intra-Abdominal Denervation for Type 2 Diabetes Mellitus), including 40 research subjects with type 2 diabetes mellitus and obesity class I. In order to analise the effect on weight loss and glycemic control after 2 years of follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ileal interposition sleeve sympathectomy | Experimental | Procedure: ileal interposition with sleeve and sympathectomylaparoscopic ileal interposition with sleeve and sympathectomy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Documented diagnosis of type 2 diabetes mellitus
- Both sexes were treated with oral antidiabetic agents and / or insulin except the current treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase 4 inhibitors
- Stable antidiabetic medication within the last 8 weeks prior to randomization (V2), if therapy includes insulin, the average daily dose should not have changed by more than 10% in the past 8 weeks
- HbA1c> 8.0%
- Age> 20 years and <60 years
Key exclusion criteria (12 listed)
- Type 1 diabetes mellitus (positive for anti-GAD), or GAD negative anti anti body with low β cell function (C-peptide after stimulation <0.5 ng / ml)
- Current treatment with GLP-1 receptor agonist and / or dipeptidyl peptidase 4 inhibitors
- Recent vascular event (myocardial infarction, coronary angioplasty or stroke in the past 6 months)
- Malignant neoplasm
- Portal hypertension
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 |
|---|---|---|
| ileal interposition with sleeve and sympathectomylaparoscopic ileal interposition with sleeve and sympathectomy | Procedure or surgery | ileal interposition sleeve sympathectomy |
Primary outcome
glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications
Time frame: 2 YEARS
Success Rate of Biochemical Resolution of Diabetes at 24 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ileal interposition with sleeve and sympathectomy in people with Diabetes Mellitus and Obesity, run by Universidade Positivo.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin(HbA1c) level of 6.0% or less, without the use of diabetes medications (time frame: 2 YEARS). 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 Jul 2026.