Clinical trial NCT02553213: Early Changes of Diabetes Parameters After Obesity Therapy
Official title: Early Changes of Diabetes Parameters After Obesity Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
name: Karl-Olga-Krankenhaus Stuttgart
First posted: 2015-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of insulin
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Change of blood glucose
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
Secondary outcomes:
Other outcomes:
measure: Changes regarding markers of glucose metabolism
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of body weight
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of blood lipids
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes concerning the intake of calories and nutrients
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of gastrointestinal hormones
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of adiponectin
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of bile acids
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of gut microbiota composition
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of body height
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
measure: Changes of body composition
timeFrame: Within 5 days after surgery or 5 days after start of caloric restriction
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
name: Stephan C. Bischoff, Prof.
role: STUDY_CHAIR
affiliation: Department of General, Visceral, and Transplant Surgery, University Hospital Tübingen, Germany
name: Alfred Königsrainer, Prof.
role: STUDY_DIRECTOR
References: