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Type 2 Diabetes MellitusBariglykosNCT02729246

Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms

A study testing Laparoscopic Gastric Bypass in people with Type 2 Diabetes Mellitus and Obesity, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Type 2 Diabetes Mellitus, Obesity
What is being tested?
Laparoscopic Gastric Bypass
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteSweden
Study dates
Oct 2014to 10 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism

    Uppsala

Other trials in Sweden

About this study

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.

Being tested
Laparoscopic Gastric Bypass
Medical subject headings
Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Gastric BypassProcedure or surgery

Study groups in NCT02729246
Study groupRoleWhat they receive
Control GroupNo interventionNot described
Surgery GroupOtherThe patients in this group will undergo Laparoscopic Gastric Bypass surgery
Receives: Procedure: Laparoscopic Gastric Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline of Glucose Turnover

    Measured: 1 month after surgery

  2. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance

    Measured: 1 month after surgery

  3. Change from Baseline of beta cell function

    Measured: 1 month after surgery

Secondary outcomes (6)

  1. Change from Baseline of Glucose Turnover

    Measured: 6 months after surgery

  2. Change from Baseline of Glucose Turnover

    Measured: 24 months after surgery

  3. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance

    Measured: 6 months after surgery

  4. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance

    Measured: 24 months after surgery

  5. Change from Baseline of beta cell function

    Measured: 6 months after surgery

  6. Change from Baseline of beta cell function

    Measured: 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startOct 2014
  3. Primary completion30 Dec 2019
  4. Study completion10 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02729246
Sponsor's protocol ID
Dnr 2014/255
Acronym
Bariglykos
Status last verified
Mar 2020
First submitted
16 Mar 2016
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Fanni G, Katsogiannos P, Sundbom M, Leksell J, Randell E. Qualitative and Quantitative Health-Related Quality-of-Life Outcomes From an 8-year Follow-Up After Gastric Bypass Surgery in People With Type 2 Diabetes. Endocrinol Diabetes Metab. 2026 Sep;9(5):e70315. doi: 10.1002/edm2.70315.

    PubMed 42615277

  • 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.

    PubMed 34086911

  • 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.

    PubMed 33062061

  • 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.

    PubMed 30689903

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic Gastric Bypass in people with Type 2 Diabetes Mellitus and Obesity, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline of Glucose Turnover (time frame: 1 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02729246, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

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