Early Glycaemic Control in Type 2 Diabetes Patients After Bariatric Surgery; ECODABS

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2 in Obese
• Intervention / Treatment: Procedure: Roux-en-Y gastric bypass; Procedure: Sleeve gastrectomy

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 Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, B-9000
    • Gent University Hospital
  • Edegem
    • Antwerp, Edegem, Belgium, B-2650
      • Antwerp University Hospital
  • Jette
    • Brussel, Jette, Belgium, B-1090
      • Universitair Ziekenhuis
• Spain
  • Madrid, Spain
    • Hospital Clinico San Carlos
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska University Hospital
  • Gothenburg, Sweden, SE-41345
    • Sahlgrenska University Hospital
  • Stockholm, Sweden, SE-116 91
    • Karolinska Institutet
• United Kingdom
  • London, United Kingdom, SW7 2AZ
    • South kensington campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

diabetes mellitus typ 2 and obesity

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glycemic control	To compare these changes in glycemic control after different techniques for bariatric surgery	day one post op to 2-3 weeks after surgery

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Karolinska Institutet; Imperial College London; University Hospital, Ghent; Universitair Ziekenhuis Brussel; University Hospital, Antwerp; Hospital San Carlos, Madrid
• Investigators: Principal Investigator: Ville Wallenius, Ass. Prof., Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 016/12