Study Results
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Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2019-03-28
2024-08-31
Brief Summary
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This study will monitor the endocrine dynamics after different anatomical modifications produced by Roux-en-Y gastric bypass procedures in diabetic participants and normoglycemic participants, to gain insights into the mechanisms beyond the metabolic improvement after the two surgical variants through participants re-evaluation at different time points.
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Detailed Description
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Obesity prevalence is a major risk factor for the onset of type 2 diabetes. Diabetic patients are frequently overweight or obese and diabetes complications are the main cause of obesity-related morbimortality, demanding proper and effective clinical management.
Bariatric surgery, originally conceived for obesity treatment, has proven not only to be the most effective weight loss intervention but also for comorbidity management, with a strong impact on type 2 diabetes. As the antidiabetic effects of bariatric surgery largely exceed the metabolic improvement predicted by the caloric restriction and weight loss, which are mostly driven by the enteroendocrine response, this challenges the academic and medical communities with the need to learn how to leverage the enteroendocrine system to achieve glucose homeostasis.
Supported on the investigators' previous work focusing on gastro-intestinal hormones and glucose metabolism after bariatric surgery, the investigators now aim to monitor the intestinal hormone after different anatomical modifications produced by Roux-en-Y gastric bypass procedures in diabetic participants and normoglycemic individuals. The utmost goal will be to unravel the endocrine mechanisms beyond the metabolic improvement observed after the surgical manipulations, towards the identification of novel targets for hormone based treatments in an individualised clinical approach.
Study Overview: Participants in this study will be submitted to either short or long BPL RYGB surgery. Participants visits will be scheduled before surgery and after surgery at 3, 6 and 12 months for detailed participants assessment that will include anthropometric and biochemical evaluation and the performance of a MMTT with plasma sampling for hormonal profiles.
Participant Enrolment: Participants will be selected from the cohort of patients referred for multidisciplinary evaluation by the clinical team for surgical treatment of obesity of the Centro Hospitalar Entre Douro e Vouga (CHEDV). Participants found to be suitable according to the entry criteria and accept to participate will be enrolled in the study and assigned to one of the three study groups according to participants clinical features.
Study Chair: Mário Nora, MD
Principal Investigator: Marta Guimarães, MD, PhD
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short BPL RYGB in glucose-tolerant participants
Procedure: short biliopancreatic limb (BPL) Roux en Y Gastric Bypass (RYGB) Obese patients without type 2 diabetes mellitus (T2DM) to be submitted to short BPL (n=10)
Short BPL RYGB
Alimentary limb (AL) with 120 cm and BPL with 100 cm.
Long BPL RYGB in glucose-tolerant participants
Procedure: long BPL RYGB Obese patients with metabolic syndrome without T2DM to be submitted to long BPL (n=10)
Long BPL RYGB
AL with 120 cm and BPL with 200 cm.
Long BPL RYGB in diabetic participants
Procedure: long BPL RYGB Obese patients with metabolic syndrome and T2DM to be submitted to long BPL (n=10)
Long BPL RYGB
AL with 120 cm and BPL with 200 cm.
Interventions
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Short BPL RYGB
Alimentary limb (AL) with 120 cm and BPL with 100 cm.
Long BPL RYGB
AL with 120 cm and BPL with 200 cm.
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 65 years at surgery
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Instituto de Ciências Biomédicas Abel Salazar
OTHER
The Novo Nordisk Foundation Center for Basic Metabolic Research
OTHER
Hospital de Sao Sebastiao
OTHER
Responsible Party
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Marta Guimarães
SURIDIAB-1 Principal investigator
Locations
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São Sebastião Hospital
Santa Maria da Feira, Aveiro District, Portugal
Countries
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Other Identifiers
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Hsebastião
Identifier Type: -
Identifier Source: org_study_id
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