Early Changes of Diabetes Parameters After Obesity Therapy
NCT ID: NCT02553213
Last Updated: 2018-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-07-31
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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LSG group
Laparoscopic sleeve gastrectomy
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.
easy digestible diet
LRYGB group
Laparoscopic Roux-en-Y gastric bypass
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.
easy digestible diet
Control group
Caloric restriction
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Karl-Olga-Krankenhaus Stuttgart
UNKNOWN
University of Hohenheim
OTHER
Responsible Party
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Principal Investigators
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Stephan C. Bischoff, Prof.
Role: STUDY_CHAIR
Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
Alfred Königsrainer, Prof.
Role: STUDY_DIRECTOR
Department of General, Visceral, and Transplant Surgery, University Hospital Tübingen, Germany
Locations
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University of Hohenheim
Stuttgart, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Studie_ECODO
Identifier Type: -
Identifier Source: org_study_id
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