Early Changes of Diabetes Parameters After Obesity Therapy

Bariatric Surgery Candidate Clinical Trial

— ECODO  

Official title:

Early Changes of Diabetes Parameters After Obesity Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02553213
• Other study ID #: Studie_ECODO
• Status: Recruiting
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2019

Study information

• Verified date: May 2018
• Source: University of Hohenheim
• Contact: Anna Schweinlin
• Phone: +4971145924880
• Email: anna.schweinlin[@]uni-hohenheim.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.
• 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.
• 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.
• easy digestible diet

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (3)

Lead Sponsor	Collaborator
University of Hohenheim	Karl-Olga-Krankenhaus Stuttgart, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes of body weight		Within 5 days after surgery or 5 days after start of caloric restriction
Other	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
Other	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
Other	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
Other	Changes of adiponectin		Within 5 days after surgery or 5 days after start of caloric restriction
Other	Changes of bile acids		Within 5 days after surgery or 5 days after start of caloric restriction
Other	Changes of gut microbiota composition		Within 5 days after surgery or 5 days after start of caloric restriction
Other	Changes of body height		Within 5 days after surgery or 5 days after start of caloric restriction
Other	Changes of body composition	measured by Body Impedance Analysis	Within 5 days after surgery or 5 days after start of caloric restriction
Primary	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
Primary	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