Metabolic SurgeryNCT03412253
Could Single-anastomosis Gastric Bypass Be a Curative Treatment for Type II Diabetes?
A study testing Single-Anastomosis Gastric Bypass surgery (SAGB). in people with Metabolic Surgery, run by Ain Shams University.
Trial summary
Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Metabolic Surgery
- What is being tested?
- Single-Anastomosis Gastric Bypass surgery (SAGB).
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 4 Feb 2018
- 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
- .Type II diabetic patients.
- Age: 20-60 years.
- either gender.
Who cannot join
- Previous bariatric surgery.
- Controlled T2DM.
- Duration of T2DM >10 years.
- Patients with endocrinal diseases,
- Pregnancy.
- Those unfit for general anesthesia.
About this study
Official title: From Diabetes Care to Diabetes Cure; Could Single-anastomosis Gastric Bypass Be a Safe Bridge to Reach This Target in Non-Obese Patients?
Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm
Read the detailed description
Background: T2DM has been considered as a chronic progressive incurable metabolic disease. Single-anastomosis gastric bypass (SAGB) was shown to be effective in obese patients in terms of weight reduction and T2DM remission, yet its effect on non-obese diabetics is not extensively studied. In this study, we tried to determine the anthropometric and glycemic outcomes of SAGB as a proposed line of treatment for type II diabetes mellitus (T2DM) patients with body mass index (BMI) 25-30 kg/m2.
Methods: From November 2013 to March 2016, a prospective study has been conducted at Ain-Shams University hospitals on 17 consecutive patients undergone SAGB. The demographic and anthropometric data of the patients, as well as their relevant laboratory results, were reported, other data including anti-diabetic medications, co-morbid metabolic diseases were also assessed. All patients were scheduled for laparoscopic SAGB and were advised to come in regular follow up at 1, 3, 6, 12 and 18 months postoperatively. T2DM Remission is considered if glycosylated hemoglobin (HbA1c) <6.5 % and fasting plasma glucose (FPG) < 126 mg/dl for at least 1 year without medication.
- Conditions
- Metabolic Surgery
- Being tested
- Single-Anastomosis Gastric Bypass surgery (SAGB).
- Keywords
- metabolic surgery, BMI 25-30 kg/m2, SAGB, T2DM remission.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Anastomosis Gastric Bypass surgery (SAGB).Procedure or surgery
Also called Mini-Gastric Bypass., One-Anastomosis Gastric Bypass.
We checked the effect of SAGB on patients suffered from T2DM with BMI 25-30
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of type II DM.
T2DM Remission is considered if glycosylated hemoglobin (HbA1c) <6.5 % and fasting plasma glucose (FPG) < 126 mg/dl for at least 1 year without medication.
Measured: 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Nov 2013
- Primary completion31 Mar 2016
- Study completion4 Feb 2018 (estimated)
Why it stopped: financial causes, and the study will be continued within days.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Abouzeid Osman Abouzeid, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412253
- Sponsor's protocol ID
- A1349
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Diabetes Care to Diabetes Cure; Could Single-anastomosis Gastric Bypass Be a Safe Bridge to Reach This Target in Non-Obese Patients?
- ClinicalTrials.gov ID
- NCT03412253
- Acronym / sponsor ID
- A1349
- Conditions
- Metabolic Surgery
- Keywords
- metabolic surgery, BMI 25-30 kg/m2, SAGB, T2DM remission.
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: financial causes, and the study will be continued within days.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 4 Feb 2018 (estimated)
- First posted
- 26 Jan 2018 (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.
Single- Anastomosis gastric bypass (SAGB) is a potentially curative line of treatment for type II diabetes mellitus (T2DM) patients with BMI 25-30 kg/m2. Accordingly, SAGB could be integrated into T2DM treatment algorithm
Detailed description
Background: T2DM has been considered as a chronic progressive incurable metabolic disease. Single-anastomosis gastric bypass (SAGB) was shown to be effective in obese patients in terms of weight reduction and T2DM remission, yet its effect on non-obese diabetics is not extensively studied. In this study, we tried to determine the anthropometric and glycemic outcomes of SAGB as a proposed line of treatment for type II diabetes mellitus (T2DM) patients with body mass index (BMI) 25-30 kg/m2.
Methods: From November 2013 to March 2016, a prospective study has been conducted at Ain-Shams University hospitals on 17 consecutive patients undergone SAGB. The demographic and anthropometric data of the patients, as well as their relevant laboratory results, were reported, other data including anti-diabetic medications, co-morbid metabolic diseases were also assessed. All patients were scheduled for laparoscopic SAGB and were advised to come in regular follow up at 1, 3, 6, 12 and 18 months postoperatively. T2DM Remission is considered if glycosylated hemoglobin (HbA1c) <6.5 % and fasting plasma glucose (FPG) < 126 mg/dl for at least 1 year without medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- .Type II diabetic patients.
- Age: 20-60 years.
- either gender.
Key exclusion criteria (6 listed)
- Previous bariatric surgery.
- Controlled T2DM.
- Duration of T2DM >10 years.
- Patients with endocrinal diseases,
- Pregnancy.
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 |
|---|---|---|
| Single-Anastomosis Gastric Bypass surgery (SAGB).Also: Mini-Gastric Bypass., One-Anastomosis Gastric Bypass.We checked the effect of SAGB on patients suffered from T2DM with BMI 25-30 | Procedure or surgery | – |
Primary outcome
Cure of type II DM.
Time frame: 1Year
T2DM Remission is considered if glycosylated hemoglobin (HbA1c) <6.5 % and fasting plasma glucose (FPG) < 126 mg/dl for at least 1 year without medication.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- 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.
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 Single-Anastomosis Gastric Bypass surgery (SAGB). in people with Metabolic Surgery, run by Ain Shams University.
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 3 inclusion and 6 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: paused, as of the sponsor's last update on 26 Jan 2018. 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?
Results are not available in the source record.
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?
Cure of type II DM. (time frame: 1Year). 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 26 Jan 2018.