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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Belgium

Sweden3 sites
  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Sahlgrenska University Hospital

    Gothenburg, SE-41345

  • Karolinska Institutet

    Stockholm, SE-116 91

Other trials in Sweden

Spain1 site
  • Hospital Clinico San Carlos

    Madrid

Other trials in Spain

United Kingdom1 site
  • South kensington campus

    London, SW7 2AZ

Other trials in United Kingdom

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.

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 groups in NCT04314427
Study groupRoleWhat they receive
Gastric by-passRoux-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 gastrectomySleeve 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.

  1. 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)
  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.

  1. First posted19 Mar 2020
  2. Study startSep 2012
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

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)
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

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.

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