Clinical trial NCT02729246: Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
Official title: Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this project is to further explore the metabolic effects and the mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both pre-diabetic as well as diabetic subjects with obesity will be included. This part of the project focuses on patients with manifest T2D and they will be assigned to surgical and non-surgical intervention, respectively, in a strictly controlled and randomized manner.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 18-60 years
* Type 2 Diabetes Mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or Glucagon-like peptide-1 (GLP-1) analog.

Exclusion Criteria:

* Pregnant or planning to be pregnant during the study.
* Known or suspected history of significant drug abuse.
* History of alcohol abuse or excessive intake of alcohol as judged by investigator.
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
* Sleep apnea
* Any previous serious cardiovascular event, stroke , acute myocardial infarction.
* Diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an Estimated Glomerular Filtration Rate (eGFR) \<60, foot ulcers, symptomatic neuropathy
* Medications within 3 months : Insulin, Thiazolidinediones
* Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety
* Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.

Primary outcomes:
measure: Change from Baseline of Glucose Turnover
timeFrame: 1 month after surgery
measure: Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
timeFrame: 1 month after surgery
measure: Change from Baseline of beta cell function
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Change from Baseline of Glucose Turnover
timeFrame: 6 months after surgery
measure: Change from Baseline of Glucose Turnover
timeFrame: 24 months after surgery
measure: Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
timeFrame: 6 months after surgery
measure: Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
timeFrame: 24 months after surgery
measure: Change from Baseline of beta cell function
timeFrame: 6 months after surgery
measure: Change from Baseline of beta cell function
timeFrame: 24 months after surgery
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism
Study officials:
affiliation: Department of Medical Sciences, Clinical diabetology and metabolism
name: Jan Eriksson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almby KE, Katsogiannos P, Pereira MJ, Karlsson FA, Sundbom M, Wiklund U, Kamble PG, Eriksson JW. Time Course of Metabolic, Neuroendocrine, and Adipose Effects During 2 Years of Follow-up After Gastric Bypass in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4049-e4061. doi: 10.1210/clinem/dgab398.
citation: Katsogiannos P, Randell E, Sundbom M, Rosenblad A, Eriksson JW, Leksell J. Quality of life after gastric bypass surgery in patients with type 2 diabetes: patients' experiences during 2 years of follow-up. Diabetol Metab Syndr. 2020 Oct 12;12:90. doi: 10.1186/s13098-020-00597-1. eCollection 2020.
citation: Katsogiannos P, Kamble PG, Boersma GJ, Karlsson FA, Lundkvist P, Sundbom M, Pereira MJ, Eriksson JW. Early Changes in Adipose Tissue Morphology, Gene Expression, and Metabolism After RYGB in Patients With Obesity and T2D. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2601-2613. doi: 10.1210/jc.2018-02165.