Early Changes of Diabetes Parameters After Obesity Therapy (ECODO)

The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.

Study Overview

• Status: Unknown
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Other: Laparoscopic sleeve gastrectomy; Other: easy digestible diet; Other: Laparoscopic Roux-en-Y gastric bypass; Other: Caloric restriction diet

Detailed Description

Previous studies have shown, that laparoscopic Roux-en-Y gastric bypass (LRYGB), and also laparoscopic sleeve gastrectomy (LSG) leed to a significant improvement of glucose metabolism and in many cases to a complete remission of diabetes type II in obese patients. It is still unclear which mechanisms underlie these changes. Since the positive effects of bariatric surgery have been investigated within few days after surgical intervention, before significant weight loss has been achieved, the caloric restriction has been discussed as a possible mechanism.

The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients. Therefore, the investigator will examine obese patients with diabetes type II or impaired glucose metabolism regarding possible metabolic changes within few days after bariatric surgery (LSG or LRYGB) or caloric restriction only.

Group I: Patients undergoing LSG; Group II: Patients undergoing LRYGB; Group III (Control group): Patients undergoing caloric restriction;

Dietetic, anthropometric, metabolic and hormonal parameters will be measured. Primary outcome marker is the insulin sensitivity according to Matsuda (MISI).

The project is a prospective, controlled study. Study examinations will be performed before intervention, and one, two, three, four and five days after (start of) intervention, as well after one month.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany
    • Recruiting
    • University of Hohenheim
    • Contact: Anna Schweinlin; Phone Number: +4971145924880+4970712986584; Email: anna.schweinlin@uni-hohenheim.de

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

Description

Inclusion Criteria:

• BMI (Body Mass Index) ≥ 35 kg/m2
• Clinical diagnosis of type II diabetes or impaired glucose metabolism (Prediabetes: HbA1c > 5,7%, fasting glucose in capillary blood > 110 mg/dl - diagnosed by blood glucose test at the first study examination)
• Regarding the patients of the surgical groups: Indication to surgical therapy of obesity (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass). The indication to surgery is independent of the study. The surgeon decides about that in the clinical routine according to the German S3 guideline.
• Written consent to participate int he study

Exclusion Criteria:

• Medication use which affects glucose metabolism, except for diabetes medication (for example: glucocorticoids)
• Insulin need >1,0 IU/kg/d
• Experimental diabetes medication within the last three months
• Pregnancy
• Gastrointestinal diseases
• Uncontrolled hypo- or hyperthyroidism
• Status after bariatric or other gastrointestinal surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LSG group; Laparoscopic sleeve gastrectomy	Other: Laparoscopic sleeve gastrectomy; The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food.; Other: easy digestible diet
Experimental: LRYGB group; Laparoscopic Roux-en-Y gastric bypass	Other: easy digestible diet; Other: Laparoscopic Roux-en-Y gastric bypass; The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food.
Other: Control group; Caloric restriction	Other: Caloric restriction diet; Patients of the control group do not undergo surgical treatment. They undergo a caloric restriction diet for 5 days. This diet is adapted to the postoperative diet of the patients included in the two other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of insulin	Blood insulin is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index	Within 5 days after surgery or 5 days after start of caloric restriction
Change of blood glucose	Blood glucose is measured during a Mixed Meal Tolerance Test (MMTT). It is used to calculate the Homeostasis Model Assessment (HOMA) and Matsuda Insulin Sensitivity Index	Within 5 days after surgery or 5 days after start of caloric restriction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes regarding markers of glucose metabolism	HbA1c, C-Peptid, insulin and fasting glucose	Within 5 days after surgery or 5 days after start of caloric restriction
Changes of body weight		Within 5 days after surgery or 5 days after start of caloric restriction
Changes of blood lipids	High density lipoprotein, low density lipoprotein, triglycerides, free fatty acids	Within 5 days after surgery or 5 days after start of caloric restriction
Changes concerning the intake of calories and nutrients	Measured by using nutritional protocols	Within 5 days after surgery or 5 days after start of caloric restriction
Changes of gastrointestinal hormones	Glucagon-like peptide-1, Ghrelin, Glucose-dependent insulinotropic peptide	Within 5 days after surgery or 5 days after start of caloric restriction
Changes of adiponectin		Within 5 days after surgery or 5 days after start of caloric restriction
Changes of bile acids		Within 5 days after surgery or 5 days after start of caloric restriction
Changes of gut microbiota composition		Within 5 days after surgery or 5 days after start of caloric restriction
Changes of body height		Within 5 days after surgery or 5 days after start of caloric restriction
Changes of body composition	measured by Body Impedance Analysis	Within 5 days after surgery or 5 days after start of caloric restriction

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: University Hospital Tuebingen; Karl-Olga-Krankenhaus Stuttgart
• Investigators: Study Chair: Stephan C. Bischoff, Prof., Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany; Study Director: Alfred Königsrainer, Prof., Department of General, Visceral, and Transplant Surgery, University Hospital Tübingen, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: Studie_ECODO