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Trial record 1 of 1 for:    bariglykos
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Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms (Bariglykos)

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ClinicalTrials.gov Identifier: NCT02729246
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Uppsala University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obesity Procedure: Laparoscopic Gastric Bypass Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
Study Start Date : October 2014
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : February 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Surgery Group
The patients in this group will undergo Laparoscopic Gastric Bypass surgery
Procedure: Laparoscopic Gastric Bypass



Primary Outcome Measures :
  1. Change from Baseline of Glucose Turnover [ Time Frame: 1 month after surgery ]
  2. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance [ Time Frame: 1 month after surgery ]
  3. Change from Baseline of beta cell function [ Time Frame: 1 month after surgery ]

Secondary Outcome Measures :
  1. Change from Baseline of Glucose Turnover [ Time Frame: 6 months after surgery ]
  2. Change from Baseline of Glucose Turnover [ Time Frame: 24 months after surgery ]
  3. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance [ Time Frame: 6 months after surgery ]
  4. Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance [ Time Frame: 24 months after surgery ]
  5. Change from Baseline of beta cell function [ Time Frame: 6 months after surgery ]
  6. Change from Baseline of beta cell function [ Time Frame: 24 months after surgery ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729246


Locations
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Sweden
Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Jan Eriksson, Professor Department of Medical Sciences, Clinical diabetology and metabolism
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02729246    
Other Study ID Numbers: Dnr 2014/255
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases