Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
Bariglykos
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Oct 2014
Longer than P75 for not_applicable type-2-diabetes-mellitus
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
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2020
CompletedMarch 31, 2020
March 1, 2020
5.2 years
March 16, 2016
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Change from Baseline of Glucose Turnover
1 month after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
1 month after surgery
Change from Baseline of beta cell function
1 month after surgery
Secondary Outcomes (6)
Change from Baseline of Glucose Turnover
6 months after surgery
Change from Baseline of Glucose Turnover
24 months after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
6 months after surgery
Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
24 months after surgery
Change from Baseline of beta cell function
6 months after surgery
- +1 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONSurgery Group
OTHERThe patients in this group will undergo Laparoscopic Gastric Bypass surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism
Uppsala, Sweden
Related Publications (3)
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.
PMID: 34086911DERIVEDKatsogiannos 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.
PMID: 33062061DERIVEDKatsogiannos 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.
PMID: 30689903DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Eriksson, Professor
Department of Medical Sciences, Clinical diabetology and metabolism
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2016
First Posted
April 6, 2016
Study Start
October 1, 2014
Primary Completion
December 30, 2019
Study Completion
February 10, 2020
Last Updated
March 31, 2020
Record last verified: 2020-03