Health TrialsbyHealthPanel

The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism

ConditionsObesityDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorGerman Diabetes Center

About this trial

The purpose of this study is:

1. To explore to what extent insulin sensitivity, energy metabolism and ectopic lipid storage can be improved by bariatric surgery 2. To explore to what extent hepatic and muscular disorders of energy metabolism occur in patients with obesity (degree 2-3) 3. To explore whether the steato liver occurring in patients with obesity (degree 2-3) is associated with the degree of liver inflammation

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged ≥ 20 years- ≤ 70 years

BMI 20- 25 kg/m 2 normal- weight group

BMI 35- 39,9 kg/m 2 (Obesity grade 2)

BMI >40 kg/m 2 (Obesity grade 3)

Disqualifiers

Acute illness 2 weeks before start of examination

Autoimmune or Immune disorder diseases (Leukozyten < 5000/µl

Renal insufficiency (Kreatin > 1,5 mg/dl)

Heart disease, condition after heart attack

Trial population

People with obesity and various stages of MASLD, that qualify for bariatric surgery.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • surgery

    Procedure/Surgery

    biliopancreatic diversion, gastric banding, gastric sleeve resection

Treatment groups

450 Participants
are divided into 1 treatment group
Group A: Surgery1 intervention

Trial outcomes

Primary outcomes

1

Energy metabolism

whole body substrate oxidation, ex vivo mitochondrial function via measurement of high resolution respirometry and in vivo mitochondrial function via measurement of ATP production

Time frame
5 years

Secondary outcomes

1

weight loss

body weight and body composition before and after bariatric surgery

Time frame
5 years
2

Insulin sensitivity

Whole body glucose uptake and endogenous glucose production as measure of skeletal muscle and hepatic insulin sensitivity

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Diabetes Center

Lead sponsor

Dep.of General-, Visceral- and Pediatric Surgery, HHU, Duesseldorf, Germany

Collaborator

Dep.for Metabolic Diseases, HHU, Duesseldorf, Germany

Collaborator

Hospital Neuwerk, Mönchengladbach, Duesseldorf, Germany

Collaborator

Source ClinicalTrials.gov
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