Beneficial effects of caloric and protein restriction on markers of the stress response and postoperative recovery

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 315

Inclusion Criteria

- scheduled for (phase 1a) or undergoing (phase 2a) laparoscopic live kidney nephrectomy
- scheduled for (phase 1b, phase 1c, phase 1d, phase 1e) and/or undergoing (phase 2b, phase 1d, phase 1e) laparoscopic bariatric surgery

Exclusion Criteria

Phase 1a (awaiting live kidney donation):
- Allergic to any of the ingredients of the diet
- Participation in another clinical trial within the last 30 days
Phase 1b (awaiting bariatric surgery):
- Allergic to any of the ingredients of the diet
- Participation in another clinical trial within the last 30 days
- BMI < 40
- Co-morbidities as in diabetes mellitus
- Morbid obesity caused by genetic defects or syndromes
Phase 1c (telomere length measurement):
- BMI < 40
- Co-morbidities as in diabetes mellitus
- Morbid obesity caused by genetic defects/syndromes
Phase 1d/Phase 1e (validation of telomere lenght measurement and measurement telomerase activity):
- BMI < 35
- Morbid obesity caused by genetic defects/syndromes
Phase 2a (undergoing live kidney donation):
- Allergic to any of the ingredients of the diet
- Bilateral abnormalities of the renal arteries (origin stenosis)
- Previous operations of the kidney(s) or adrenals gland(s)
- Radiological abnormalities necessitating an open approach
- Perioperative conversion to an open approach
- Participation in another clinical trial within the last 30 days
- Usage of therapeutic anti-clotting medication
Phase 2b (undergoing bariatric surgery):
- Allergic to any of the ingredients of the diet
- Previous operations of the stomach or duodenum
- Any abnormalities necessitating an open approach
- Perioperative conversion to an open approach
- Participation in another clinical trial within the last 30 days
- Liver abnormalities found perioperatively necessitating postponing of surgery
- Preoperative risk assessment necessitating nutritional intervention
- BMI < 40
- Co-morbidity as in diabetes mellitus
- Morbid obesity caused by genetic defects or syndromes
- Usage of therapeutic anti-clotting medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Primary outcome measure in phase 1 is the objective feasibility measured as<br /><br>the percentage of patients completing the diet, reasons for not adhering to the<br /><br>diet (if applicable) and the levels of metabolic parameters.<br /><br>- Primary parameter in phase 1c is the effect of morbid obesity on different<br /><br>ages on telomere length in leukocytes.<br /><br>- Primary parameter in phase 1d/ phase 1e (validation of telomere length<br /><br>measurement and measurement telomerase activity) is the effect of morbid<br /><br>obesity, the metabole syndrome and bariatric surgery on telomere length and<br /><br>telomerase activity in leukocytes.<br /><br>- Main study parameters in phase 2 are markers of the adaptive stress response<br /><br>at mRNA and protein level measured in tissue biopsies obtained perioperatively. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Phase 1: subjective feasibility of a diet containing caloric and protein<br /><br>restriction.<br /><br>- Phase 1d/ phase 1e (measurement of telomere length): the role of bariatric<br /><br>surgery on the telomere attrition induced by morbid obesity via measurement of<br /><br>telomere lengths before and at timepoints 3, 6, 12 and 24 months after<br /><br>bariatric surgery.<br /><br>- Phase 2: the effects of a diet consisting of caloric and protein restriction<br /><br>on the subjective postoperative recovery, the acute phase response and<br /><br>metabolic parameters. </p><br>