Diabetes MellitusNCT03333642
Surgery Treatment of Type 2 Diabetes Mellitus Patients With Grade 1 Obesity and Overweight
A study testing Duodenal Ileal Interposition with Sleeve Gastrectomy in people with Diabetes Mellitus and Obesity, run by Hospital Federal de Bonsucesso at 1 site in Brazil.
Trial summary
This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Obesity, Overweight
- What is being tested?
- Duodenal Ileal Interposition with Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Nov 2017to Jul 2023
- 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
- Documented diagnosis of type 2 diabetes mellitus;
- Patients of both sexes treated with oral antidiabetic agents and / or insulins,
- Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks;
- HbA1c> 7.0%;
- Age> 20 years and <65 years;
- Body mass index (BMI) of 25 to 35 kg / m²;
- Agree to sign the consent form;
Who cannot join
- Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-cell function (peptide C after stimulation <0.5 ng / ml);
- Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months);
- Malignant neoplasm;
- Portal hypertension;
- Difficulty to cooperate with segment;
- Low ability to understand surgery;
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- Unrealistic expectations of results;
- Cognitive deficit;
- Current pregnancy;
- Moderate or severe mood disorder; severe anxiety; eating disorders (based on Substance-Related Disorders DSM-V criteria);
- Chemical dependence or alcoholism (based on Substance-Related Disorders DSM-V criteria).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Federal de Bonsucesso
Rio de Janeiro, 21041-020
Leonardo R Ferraz, MD, +55 21 996462422, lrferraz1@1hotmail.com
Thiago B Abreu, MD, +55 21 996487500, boechat1@yahoo.com.br
About this study
Official title: Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment
This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.
Read the detailed description
A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on glycemic control after 2 years of follow-up.
- Conditions
- Diabetes Mellitus, Obesity, Overweight
- Being tested
- Duodenal Ileal Interposition with Sleeve Gastrectomy
- Keywords
- diabetes, metabolic surgery, ileal interposition
- Medical subject headings
- Diabetes Mellitus, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duodenal Ileal Interposition with Sleeve GastrectomyProcedure or surgery
Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Duodenal Ileal interposition | Experimental | Duodenal Ileal Interposition with Sleeve Gastrectomy. Receives: Procedure: Duodenal Ileal Interposition with Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of type 2 Diabetes at 24 months
Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications
Measured: 2 years
Secondary outcomes (1)
Control of type 2 diabetes
Number of patients with glycated hemoglobin (HbA1c) < 6.5%, but still in use of oral anti diabetic drugs and/or insulin
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 posted7 Nov 2017
- Study start27 Nov 2017
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Federal de Bonsucesso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Rocha Ferraz, Hospital Federal de Bonsucesso
- Investigators
- Leonardo R Ferraz, MD, Principal investigator, Hospital Federal de Bonsucesso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333642
- Sponsor's protocol ID
- 67955917.2.0000.5253
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ileal Interposition With Sleeve Gastrectomy for Type 2 Diabetes Mellitus Treatment
- ClinicalTrials.gov ID
- NCT03333642
- Acronym / sponsor ID
- 67955917.2.0000.5253
- Conditions
- Diabetes Mellitus, Obesity, Overweight
- Keywords
- diabetes, metabolic surgery, ileal interposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Federal de BonsucessoUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 7 Nov 2017 (actual)
- 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.
This study evaluate the Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus in grade 1 obesity and overweight patients.
Detailed description
A clinical trial, 1-arm treatment (Duodenal Ileal Interposition with Sleeve Gastrectomy for Type 2 Diabetes Mellitus), including 50 research subjects with type 2 diabetes mellitus and obesity class I or overweight. The main objective is to analyse the effect on 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 |
|---|---|---|
| Duodenal Ileal interposition | Experimental | Procedure: Duodenal Ileal Interposition with Sleeve GastrectomyDuodenal Ileal Interposition with Sleeve Gastrectomy. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented diagnosis of type 2 diabetes mellitus;
- Patients of both sexes treated with oral antidiabetic agents and / or insulins,
- Stable antidiabetic medication in the last 8 weeks prior to selection, if the therapy includes insulin, the mean daily dose should not have been changed by more than 10% in the last 8 weeks;
- HbA1c> 7.0%;
- Age> 20 years and <65 years;
Key exclusion criteria (11 listed)
- Diabetes mellitus type 1 (anti-glutamic acid decarboxylase(GAD) positive) or anti-GAD negative body with low β-cell function (peptide C after stimulation <0.5 ng / ml);
- Recent vascular event (myocardial infarction, coronary angioplasty or encephalic vascular accident in the last 6 months);
- Malignant neoplasm;
- Portal hypertension;
- Difficulty to cooperate with segment;
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 |
|---|---|---|
| Duodenal Ileal Interposition with Sleeve GastrectomyLaparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy | Procedure or surgery | Duodenal Ileal interposition |
Primary outcome
Remission of type 2 Diabetes at 24 months
Time frame: 2 years
Number of patients with glycated hemoglobin (HbA1c) of 6.0% or less, without use of diabetes medications
1 secondary outcome
Control of type 2 diabetes
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
Leonardo R Ferraz, MD principal investigator
Hospital Federal de Bonsucesso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duodenal Ileal Interposition with Sleeve Gastrectomy in people with Diabetes Mellitus and Obesity, run by Hospital Federal de Bonsucesso at 1 site in Brazil.
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 11 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 14 Oct 2020. 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 Brazil. 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 Leonardo R Ferraz, MD (+55 21 996462422, lrferraz1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of type 2 Diabetes at 24 months (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 14 Oct 2020.