The Effect of Bariatric Surgery on Insulin Sensitivity and Energy Metabolism
BARIA-DDZ
1 other identifier
observational
450
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2011
CompletedFirst Posted
Study publicly available on registry
November 23, 2011
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
January 10, 2025
December 1, 2024
16.3 years
November 13, 2011
January 9, 2025
Conditions
Keywords
Outcome Measures
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
5 years
Secondary Outcomes (2)
weight loss
5 years
Insulin sensitivity
5 years
Study Arms (1)
Surgery
bariatric surgery
Interventions
biliopancreatic diversion, gastric banding, gastric sleeve resection
Eligibility Criteria
People with obesity and various stages of MASLD, that qualify for bariatric surgery.
You may qualify if:
- 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)
You may not qualify if:
- 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
- Anemia (Hb \<12g/l, controlled before every day of examination) or blood donations 4weeks before examination.
- Participation in another trial within the last 2 weeks
- Pharmacological- immunotherapy (Cortisol, Antihistaminika, ASS)
- Thyroid disorders
- Glitazone Therapy
- Pregnancy, Lactation, Menstruation
- Smoking cigarettes, Alcohol- and drug abuse
- Psychiatric disorders
- Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
- Liver disease, which are not caused by non- alcoholic steato- hepatitis
- Working on night shifts or irregular rhythm of night- day
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (5)
Koliaki C, Szendroedi J, Kaul K, Jelenik T, Nowotny P, Jankowiak F, Herder C, Carstensen M, Krausch M, Knoefel WT, Schlensak M, Roden M. Adaptation of hepatic mitochondrial function in humans with non-alcoholic fatty liver is lost in steatohepatitis. Cell Metab. 2015 May 5;21(5):739-46. doi: 10.1016/j.cmet.2015.04.004.
PMID: 25955209BACKGROUNDKahl S, Strassburger K, Pacini G, Trinks N, Pafili K, Mastrototaro L, Dewidar B, Sarabhai T, Trenkamp S, Esposito I, Schlensak M, Granderath FA, Roden M. Dysglycemia and liver lipid content determine the relationship of insulin resistance with hepatic OXPHOS capacity in obesity. J Hepatol. 2025 Mar;82(3):417-426. doi: 10.1016/j.jhep.2024.08.012. Epub 2024 Aug 31.
PMID: 39218222DERIVEDSarabhai T, Kahl S, Gancheva S, Mastrototaro L, Dewidar B, Pesta D, Ratter-Rieck JM, Bobrov P, Jeruschke K, Esposito I, Schlensak M, Roden M. Loss of mitochondrial adaptation associates with deterioration of mitochondrial turnover and structure in metabolic dysfunction-associated steatotic liver disease. Metabolism. 2024 Feb;151:155762. doi: 10.1016/j.metabol.2023.155762. Epub 2023 Dec 19.
PMID: 38122893DERIVEDPafili K, Kahl S, Mastrototaro L, Strassburger K, Pesta D, Herder C, Putzer J, Dewidar B, Hendlinger M, Granata C, Saatmann N, Yavas A, Gancheva S, Heilmann G, Esposito I, Schlensak M, Roden M. Mitochondrial respiration is decreased in visceral but not subcutaneous adipose tissue in obese individuals with fatty liver disease. J Hepatol. 2022 Dec;77(6):1504-1514. doi: 10.1016/j.jhep.2022.08.010. Epub 2022 Aug 19.
PMID: 35988689DERIVEDApostolopoulou M, Gordillo R, Koliaki C, Gancheva S, Jelenik T, De Filippo E, Herder C, Markgraf D, Jankowiak F, Esposito I, Schlensak M, Scherer PE, Roden M. Specific Hepatic Sphingolipids Relate to Insulin Resistance, Oxidative Stress, and Inflammation in Nonalcoholic Steatohepatitis. Diabetes Care. 2018 Jun;41(6):1235-1243. doi: 10.2337/dc17-1318. Epub 2018 Mar 30.
PMID: 29602794DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Roden, Prof., MD
German Diabetes Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2011
First Posted
November 23, 2011
Study Start
September 1, 2012
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
January 10, 2025
Record last verified: 2024-12