Diabetes Mellitus Type 2 in ObeseNCT04314427
Early Glycaemic Control in Type 2 Diabetes Patients After Bariatric Surgery; ECODABS
An observational study of Diabetes Mellitus Type 2 in Obese, run by Sahlgrenska University Hospital at 8 sites in 4 countries.
Trial summary
Describe and characterize the time-course for improvement in glucose control after bariatric surgery in obese patients with type 2 diabetes Compare these changes in glycemic control after different techniques for bariatric surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese
- What is being tested?
- Roux-en-Y gastric bypass and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Sep 2012to Mar 2018
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetes mellitus typ 2 and obesity
Who may be able to join
- Male and female type 2 diabetic patients
- Patients aged 18-65 years
- Diabetes treatment consisting of dietary measures or any of the following:
- Metformin
- Sulfonylurea
- Glinides
Show all 10Show fewer
- Glitazones
- Acarbose
- Any type of insulin
- BMI ≥ 35 kg/m2
Who cannot join
- Active alcohol abuse
- Active psychiatric illness
- MODY (maturity onset diabetes of the young)
- Type 1 diabetes
- Diabetes treatment consisting of DPP IV-inhibitors or incretin mimetics
- Pregnancy and gestational diabetes
- Prior bariatric surgery
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Belgium3 sites
Antwerp University Hospital
Antwerp, Edegem, B-2650
Universitair Ziekenhuis
Brussels, Jette, B-1090
Gent University Hospital
Ghent, B-9000
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Sahlgrenska University Hospital
Gothenburg, SE-41345
Karolinska Institutet
Stockholm, SE-116 91
About this study
Official title: Early Glycaemic Control in Type 2 Diabetes Patients After Bariatric Surgery
Describe and characterize the time-course for improvement in glucose control after bariatric surgery in obese patients with type 2 diabetes
Compare these changes in glycemic control after different techniques for bariatric surgery
Read the detailed description
Obesity and its ensuing metabolic complications such as type 2 diabetes mellitus, are exponentially increasing worldwide. * * The most effective treatment for obesity is bariatric surgery. * Different bariatric procedures are available. In the 1960's, the Roux-en-Y gastric bypass (RYGB) was developed, in which the stomach is divided with staplers to create a small gastric pouch, while the jejunum is divided 30 to 50 cm distal to the ligament of Treitz. The distal limb is then anastomosed to the small gastric pouch and a jejunojejunostomy is performed 50 to 150 cm distal from the gastrojejunostomy. Sleeve gastrectomy on the other hand, reduces the stomach size by vertical stapling. In the 1990's, gastric banding was developed, reducing the volume of the stomach by annular banding. The amount of excess body weight reduction varies among the different techniques, with 60% to 70% reported for RYGB*, 55% for sleeve gastrectomy* and up to 65% for gastric banding*. Worldwide, it is estimated that a total of 344000 procedures were performed in 2008. Roux-en-Y gastric bypass was the most common (47%) followed by gastric banding (42%) and sleeve gastrectomy (5%).*
In 1987, Pories et al. published data on the stunning observation that 99% of obese patients with type 2 diabetes or impaired glucose tolerance that had undergone Roux-en-Y gastric bypass became and remained euglycemic after surgery.* Since then, all commonly used bariatric procedures have been shown to restore a normal glucose profile in many diabetes patients. Current data suggest that the bypass procedures are more effective in doing so, with success rates up to 80%,* than the purely restrictive procedures such as sleeve gastrectomy and gastric banding, with success rates varying between 30% and 70%.* The improvement in glycaemic control is already seen a few days after surgery, long before any substantial weight loss occurs.
Although different reasons for the rapid amelioration in glycaemic control are discussed in literature, the exact underlying mechanisms are still not understood. In the restrictive procedures, the effect is thought to be mainly mediated by caloric restriction and the ensuing reduction in body weight and improvement in insulin resistance.* The malabsorptive procedures, such as RYGB, offer different explanatory possibilities. In the so-called 'fore-gut hypothesis', it is suggested that the exclusion of the duodenum and proximal jejunum may reduce insulin resistance. * The 'hind-gut hypothesis' on the other hand, suggests that it is the altered delivery of nutrients to the distal small bowel that causes exaggerated responses of the gut hormones. These gut hormones act as anorectic agents and as incretins that stimulate the beta cells in the pancreas to restore normal first phase insulin response. *
Most studies to investigate the alterations in glucose metabolism are performed weeks to months after surgery. There are limited data on the evolution of blood glucose in the first days and weeks after RYGB.* However, to our knowledge, no such data exist on the glycaemic control immediately after sleeve gastrectomy and gastric banding. With the present study we document the evolution in glycaemic control immediately after RYGB, sleeve gastrectomy and gastric banding in type 2 diabetic subjects.
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Being tested
- Roux-en-Y gastric bypass, Sleeve gastrectomy
- Keywords
- Glycemic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y gastric bypassProcedure or surgery
Sleeve gastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gastric by-pass | Roux-en-Y gastric bypass (RYGB); the stomach is divided with staplers to create a small gastric pouch, while the jejunum is divided 30 to 50 cm distal to the ligament of Treitz. The distal limb is then anastomosed to the small gastric pouch and a jejunojejunostomy is performed 50 to 150 cm distal from the gastrojejunostomy. Receives: Procedure: Roux-en-Y gastric bypass | |
| Sleeve gastrectomy | Sleeve gastrectomy reduces the stomach size by vertical stapling Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
the aim is to describe and characterize the time-course for improvement in glucose control after bariatric surgery in obese patients with type 2 diabetes
Measured: from day one to 2-3 weeks after surgery
Secondary outcomes (1)
Changes in glycemic control
To compare these changes in glycemic control after different techniques for bariatric surgery
Measured: day one post op to 2-3 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startSep 2012
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitair Ziekenhuis Brussel, Karolinska Institutet, Hospital San Carlos, Madrid, University Hospital, Ghent, Imperial College London
- Responsible party
- Principal investigator, Ville Wallenius, Sahlgrenska University Hospital
- Investigators
- Ville Wallenius, Ass. Prof., Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314427
- Sponsor's protocol ID
- 016/12
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Glycaemic Control in Type 2 Diabetes Patients After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04314427
- Acronym / sponsor ID
- 016/12
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Keywords
- Glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Universitair Ziekenhuis Brussel, Karolinska Institutet, Hospital San Carlos, Madrid, University Hospital, Ghent, Imperial College London
- Study start
- Sep 2012 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Mar 2020 (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.
Describe and characterize the time-course for improvement in glucose control after bariatric surgery in obese patients with type 2 diabetes
Compare these changes in glycemic control after different techniques for bariatric surgery
Detailed description
Obesity and its ensuing metabolic complications such as type 2 diabetes mellitus, are exponentially increasing worldwide. * * The most effective treatment for obesity is bariatric surgery. * Different bariatric procedures are available. In the 1960's, the Roux-en-Y gastric bypass (RYGB) was developed, in which the stomach is divided with staplers to create a small gastric pouch, while the jejunum is divided 30 to 50 cm distal to the ligament of Treitz. The distal limb is then anastomosed to the small gastric pouch and a jejunojejunostomy is performed 50 to 150 cm distal from the gastrojejunostomy. Sleeve gastrectomy on the other hand, reduces the stomach size by vertical stapling. In the 1990's, gastric banding was developed, reducing the volume of the stomach by annular banding. The amount of excess body weight reduction varies among the different techniques, with 60% to 70% reported for RYGB*, 55% for sleeve gastrectomy* and up to 65% for gastric banding*. Worldwide, it is estimated that a total of 344000 procedures were performed in 2008. Roux-en-Y gastric bypass was the most common (47%) followed by gastric banding (42%) and sleeve gastrectomy (5%).*
In 1987, Pories et al. published data on the stunning observation that 99% of obese patients with type 2 diabetes or impaired glucose tolerance that had undergone Roux-en-Y gastric bypass became and remained euglycemic after surgery.* Since then, all commonly used bariatric procedures have been shown to restore a normal glucose profile in many diabetes patients. Current data suggest that the bypass procedures are more effective in doing so, with success rates up to 80%,* than the purely restrictive procedures such as sleeve gastrectomy and gastric banding, with success rates varying between 30% and 70%.* The improvement in glycaemic control is already seen a few days after surgery, long before any substantial weight loss occurs.
Although different reasons for the rapid amelioration in glycaemic control are discussed in literature, the exact underlying mechanisms are still not understood. In the restrictive procedures, the effect is thought to be mainly mediated by caloric restriction and the ensuing reduction in body weight and improvement in insulin resistance.* The malabsorptive procedures, such as RYGB, offer different explanatory possibilities. In the so-called 'fore-gut hypothesis', it is suggested that the exclusion of the duodenum and proximal jejunum may reduce insulin resistance. * The 'hind-gut hypothesis' on the other hand, suggests that it is the altered delivery of nutrients to the distal small bowel that causes exaggerated responses of the gut hormones. These gut hormones act as anorectic agents and as incretins that stimulate the beta cells in the pancreas to restore normal first phase insulin response. *
Most studies to investigate the alterations in glucose metabolism are performed weeks to months after surgery. There are limited data on the evolution of blood glucose in the first days and weeks after RYGB.* However, to our knowledge, no such data exist on the glycaemic control immediately after sleeve gastrectomy and gastric banding. With the present study we document the evolution in glycaemic control immediately after RYGB, sleeve gastrectomy and gastric banding in type 2 diabetic subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric by-pass | – | Procedure: Roux-en-Y gastric bypassRoux-en-Y gastric bypass (RYGB); the stomach is divided with staplers to create a small gastric pouch, while the jejunum is divided 30 to 50 cm distal to the ligament of Treitz. The distal limb is then anastomosed to the small gastric pouch and a jejunojejunostomy is performed 50 to 150 cm distal from the gastrojejunostomy. |
| Sleeve gastrectomy | – | Procedure: Sleeve gastrectomySleeve gastrectomy reduces the stomach size by vertical stapling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetes mellitus typ 2 and obesity
Key inclusion criteria (10 listed)
- Male and female type 2 diabetic patients
- Patients aged 18-65 years
- Diabetes treatment consisting of dietary measures or any of the following:
- Metformin
- Sulfonylurea
Key exclusion criteria (7 listed)
- Active alcohol abuse
- Active psychiatric illness
- MODY (maturity onset diabetes of the young)
- Type 1 diabetes
- Diabetes treatment consisting of DPP IV-inhibitors or incretin mimetics
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 |
|---|---|---|
| Roux-en-Y gastric bypass | Procedure or surgery | Gastric by-pass |
| Sleeve gastrectomy | Procedure or surgery | Sleeve gastrectomy |
Primary outcome
Glucose control
Time frame: from day one to 2-3 weeks after surgery
the aim is to describe and characterize the time-course for improvement in glucose control after bariatric surgery in obese patients with type 2 diabetes
1 secondary outcome
Changes in glycemic control
Time frame: day one post op to 2-3 weeks after surgery
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 19 Mar 2020.
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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.
Ville Wallenius, Ass. Prof. principal investigator
Sahlgrenska University Hospital
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 in Obese, run by Sahlgrenska University Hospital at 8 sites in 4 countries.
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 10 inclusion and 7 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 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Sweden, Spain, United Kingdom. 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?
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?
Glucose control (time frame: from day one to 2-3 weeks after surgery). 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 19 Mar 2020.