Clinical trial NCT04196348: Surgical Innovation for Diabetes Treatment
Official title: Characterization of Intestinal Hormone and Glucose Dynamics to Unravel the Antidiabetic Effect of Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Keywords: Bariatric Surgery
Gastric Bypass
Obesity
Type 2 Diabetes Mellitus
Metabolic Syndrome
Lead sponsor: Hospital de Sao Sebastiao
Sponsor class: OTHER
Collaborators: name: Instituto de Ciências Biomédicas Abel Salazar
name: The Novo Nordisk Foundation Center for Basic Metabolic Research
First posted: 2019-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine how two variants of gastric bypass induce changes in dynamic endocrine response in the fasting and post-prandial state, both before and at different time points after the surgical interventions.

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.

Detailed description: Abstract

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

Eligibility criteria: Inclusion Criteria:

* BMI between 35 and 45 kg/m2 with indication for bariatric surgery
* Aged between 18 and 65 years at surgery

Exclusion Criteria:

* Unwillingness, inability or intolerance to complete the MMTT (ingest 200 mL in 15 minutes or less)

Primary outcomes:
measure: Change in body mass index
timeFrame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
measure: Change in glycated haemoglobin
timeFrame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
measure: Change in glucose dynamic profile
timeFrame: Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
measure: Change in insulin dynamic profile
timeFrame: Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
measure: Change in glucagon dynamic profile
timeFrame: Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
measure: Change in GLP-1 dynamic profile
timeFrame: Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
measure: Change in GIP dynamic profile
timeFrame: Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria Da Feira
country: Portugal
facility: São Sebastião Hospital
state: Aveiro
Study officials:
References: