NCT04314427

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

5.5 years

First QC Date

March 17, 2020

Last Update Submit

March 17, 2020

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

Glycemic control

Outcome Measures

Primary Outcomes (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

    from day one to 2-3 weeks after surgery

Secondary Outcomes (1)

  • Changes in glycemic control

    day one post op to 2-3 weeks after surgery

Study Arms (2)

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.

Procedure: Roux-en-Y gastric bypass

Sleeve gastrectomy

Sleeve gastrectomy reduces the stomach size by vertical stapling

Procedure: Sleeve gastrectomy

Interventions

Roux-en-Y gastric bypassPROCEDURE
Gastric by-pass
Sleeve gastrectomyPROCEDURE
Sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetes mellitus typ 2 and obesity

You may qualify if:

  • 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
  • Glitazones
  • Acarbose
  • Any type of insulin
  • BMI ≥ 35 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Antwerp University Hospital

Antwerp, Edegem, B-2650, Belgium

Location

Universitair Ziekenhuis

Brussels, Jette, B-1090, Belgium

Location

Gent University Hospital

Ghent, B-9000, Belgium

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, SE-41345, Sweden

Location

Karolinska Institutet

Stockholm, SE-116 91, Sweden

Location

South kensington campus

London, SW7 2AZ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma Serum

MeSH Terms

Interventions

Gastric Bypass

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Ville Wallenius, Ass. Prof.

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

September 1, 2012

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 19, 2020

Record last verified: 2020-03

Locations

ES(1)GB(1)SE(3)BE(3)