Diabetes MellitusNCT03125369
Single Loop DJB Sleeve Gastrectomy for Poorly Controlled T2DM
A study testing Sleeve gastrectomy + duodeno-jejunal bypass and Roux-Y gastric bypass in people with Diabetes Mellitus and Obesity, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Obesity, Bariatric Surgery Candidate
- What is being tested?
- Sleeve gastrectomy + duodeno-jejunal bypass and Roux-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 20 to 65 years
- at least 2 years of T2DM
- a BMI between 28 to 42 kg/m2
- a HbA1c level above 7% despite multiple oral medications (> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months
- no active cardiovascular diseases, and
- a ASA grade II or below
- a fasting C-peptide < 0.6ug/L
Who cannot join
- significant anaesthetic risk ASA grade III or above
- history of diabetic ketoacidosis
- uncontrolled DM with HbA1c > 12%
- malignancy diagnosed within 5 years
- chronic renal failure requiring dialysis
- previous upper abdominal surgery affecting gastroduodenal configuration
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- major psychiatric illness including major depression and substance abuse
- pregnancy or ongoing breast-feeding
- inmates
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Enders Ng, MD, +852 26322956, endersng@surgery.cuhk.edu.hk
About this study
Official title: Prospective Randomized Trial Comparing Single Loop Duodenojejunal Bypass With Sleeve Gastrectomy Versus Standard Roux-en-Y Gastric Bypass in Patients With Poorly Controlled Type 2 Diabetes Mellitus: From Clinical Outcomes to Hormonal Mechanism
Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.
Read the detailed description
Aim of study:
To investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP).
Hypothesis:
The efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.
- Conditions
- Diabetes Mellitus, Obesity, Bariatric Surgery Candidate, Weight Loss
- Being tested
- Sleeve gastrectomy + duodeno-jejunal bypass, Roux-Y gastric bypass
- Medical subject headings
- Diabetes Mellitus, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy + duodeno-jejunal bypassProcedure or surgery
Roux-Y gastric bypassProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Duodenojejunal bypass | Experimental | patients receive sleeve gastrectomy plus duodeno-jejunal bypass Receives: Procedure: Sleeve gastrectomy + duodeno-jejunal bypass |
| Roux-en-Y gastric bypass | Active comparator | patients receive roux-Y gastric bypass Receives: Procedure: Roux-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patient achieve HbA1c<6%
Measured: 1 year
Secondary outcomes (7)
operation time
Measured: during operation
Total blood loss
Total blood loss data from operation record
Measured: during operation
Perioperative complications
Measured: 30 days
mortality
Measured: 30 days
Postoperative hospital stay
Measured: during index operation
Excessive body weight loss (kg)
Measured: 6 months & 1 year
BMI change (kg/m^2)
Measured: 6 months & 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startAug 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (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.
- More trials run by Chinese University of Hong KongThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enders K.W. Ng, Chinese University of Hong Kong
- Investigators
- Enders KW Ng, Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125369
- Sponsor's protocol ID
- SLDJBSG_DM
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2016
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Single Loop Duodenojejunal Bypass With Sleeve Gastrectomy Versus Standard Roux-en-Y Gastric Bypass in Patients With Poorly Controlled Type 2 Diabetes Mellitus: From Clinical Outcomes to Hormonal Mechanism
- ClinicalTrials.gov ID
- NCT03125369
- Acronym / sponsor ID
- SLDJBSG_DM
- Conditions
- Diabetes Mellitus, Obesity, Bariatric Surgery Candidate, Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 24 Apr 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.
Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.
Detailed description
Aim of study:
To investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP).
Hypothesis:
The efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duodenojejunal bypass | Experimental | Procedure: Sleeve gastrectomy + duodeno-jejunal bypasspatients receive sleeve gastrectomy plus duodeno-jejunal bypass |
| Roux-en-Y gastric bypass | Active comparator | Procedure: Roux-Y gastric bypasspatients receive roux-Y gastric bypass |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged between 20 to 65 years
- at least 2 years of T2DM
- a BMI between 28 to 42 kg/m2
- a HbA1c level above 7% despite multiple oral medications (> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months
- no active cardiovascular diseases, and
Key exclusion criteria (9 listed)
- significant anaesthetic risk ASA grade III or above
- history of diabetic ketoacidosis
- uncontrolled DM with HbA1c > 12%
- malignancy diagnosed within 5 years
- chronic renal failure requiring dialysis
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 |
|---|---|---|
| Sleeve gastrectomy + duodeno-jejunal bypass | Procedure or surgery | Duodenojejunal bypass |
| Roux-Y gastric bypass | Procedure or surgery | Roux-en-Y gastric bypass |
Primary outcome
% of patient achieve HbA1c<6%
Time frame: 1 year
7 secondary outcomes
operation time
Time frame: during operation
Total blood loss
Time frame: during operation
Perioperative complications
Time frame: 30 days
mortality
Time frame: 30 days
Postoperative hospital stay
Time frame: during index operation
Excessive body weight loss (kg)
Time frame: 6 months & 1 year
BMI change (kg/m^2)
Time frame: 6 months & 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- 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.
Enders KW Ng, Professor principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy + duodeno-jejunal bypass and Roux-Y gastric bypass in people with Diabetes Mellitus and Obesity, run by Chinese University of Hong Kong at 1 site in China.
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 9 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 24 Apr 2017. 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 China. 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 Enders Ng, MD (+852 26322956, endersng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of patient achieve HbA1c<6% (time frame: 1 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 24 Apr 2017.