Early Changes of Diabetes Parameters After Obesity Therapy (ECODO)

University of Hohenheim

Status: Unknown

Conditions: Bariatric Surgery Candidate

Treatments: Other: Laparoscopic Roux-en-Y gastric bypass; Other: Caloric restriction diet; Other: Laparoscopic sleeve gastrectomy; Other: easy digestible diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02553213

Studie_ECODO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

LSG group

Experimental group

Description:

Laparoscopic sleeve gastrectomy

Treatment:

Other: easy digestible diet

Other: Laparoscopic sleeve gastrectomy

LRYGB group

Experimental group

Description:

Laparoscopic Roux-en-Y gastric bypass

Treatment:

Other: Laparoscopic Roux-en-Y gastric bypass

Other: easy digestible diet

Control group

Other group

Description:

Caloric restriction

Treatment:

Other: Caloric restriction diet