NCT04196348

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

September 2, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

May 10, 2019

Last Update Submit

September 1, 2022

Conditions

ObesityDiabetes Mellitus, Type 2

Keywords

Bariatric SurgeryGastric BypassObesityType 2 Diabetes MellitusMetabolic Syndrome

Outcome Measures

Primary Outcomes (7)

  • Change in body mass index

    Body mass index (BMI) combines height (in meters) and weight (in kilograms) and is calculated as weight over (height)\^2. Therefore, it will be reported in kg/m\^2. This parameter will be determined at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) at presential visits to the clinic.

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Change in glycated haemoglobin

    Glycated haemoglobin (HbA1c) will be measured in percentage (%). This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post- surgery) through routine complete biochemical evaluation.

    From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Change in glucose dynamic profile

    Glucose will be measured in mmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).

    Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Change in insulin dynamic profile

    Insulin will be measured in mIU/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).

    Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Change in glucagon dynamic profile

    Glucagon will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).

    Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Change in GLP-1 dynamic profile

    Glucagon-like peptide-1 (GLP-1) will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).

    Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

  • Change in GIP dynamic profile

    Glucose-dependent insulinotropic polypeptide (GIP) will be measured in pmol/L. This parameter will be assessed at each study timepoint (pre-operatory, 3, 6 and 12 months post-surgery) under fasting conditions and during a mixed-meal tolerance teste (MMTT) with blood collection at eight timed intervals (-10, 0, 15, 30, 45, 60, 90 and 120 minutes).

    Time Frame: From enrolment to 12 months post-intervention in 4 visits: preoperative, 3, 6 and 12 months post-surgery

Study Arms (3)

Short BPL RYGB in glucose-tolerant participants

ACTIVE COMPARATOR

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)

Procedure: Short BPL RYGB

Long BPL RYGB in glucose-tolerant participants

ACTIVE COMPARATOR

Procedure: long BPL RYGB Obese patients with metabolic syndrome without T2DM to be submitted to long BPL (n=10)

Procedure: Long BPL RYGB

Long BPL RYGB in diabetic participants

ACTIVE COMPARATOR

Procedure: long BPL RYGB Obese patients with metabolic syndrome and T2DM to be submitted to long BPL (n=10)

Procedure: Long BPL RYGB

Interventions

Short BPL RYGBPROCEDURE

Alimentary limb (AL) with 120 cm and BPL with 100 cm.

Short BPL RYGB in glucose-tolerant participants
Long BPL RYGBPROCEDURE

AL with 120 cm and BPL with 200 cm.

Long BPL RYGB in diabetic participantsLong BPL RYGB in glucose-tolerant participants

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Sebastião Hospital

Santa Maria da Feira, Aveiro District, 4520-211, Portugal

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SURIDIAB-1 Principal investigator

Study Record Dates

First Submitted

May 10, 2019

First Posted

December 12, 2019

Study Start

March 28, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2024

Last Updated

September 2, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)