NCT03046186

Brief Summary

After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

February 6, 2017

Last Update Submit

November 25, 2020

Conditions

Obesity, MorbidBariatric Surgery

Keywords

Gastric sleeveGastric bypass

Outcome Measures

Primary Outcomes (2)

  • Glucose absorption

    Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON

    0 - 360 minutes

  • Protein absorption

    Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON

    0 - 360 minutes

Secondary Outcomes (12)

  • Glucose absorption

    0 - 360 minutes

  • Protein absorption

    0 - 360 minutes

  • Glucose kinetics

    0 - 360 minutes

  • Protein kinetics

    0 - 360 minutes

  • Insulin secretion

    0 - 240 minutes

  • +7 more secondary outcomes

Study Arms (3)

Gastric sleeve operated subjects

12 patients who have undergone gastric sleeve operation \>12 month prior to inclution.

Diagnostic Test: Mixed meal test with double tracer technique

Control Subjects

12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age

Diagnostic Test: Mixed meal test with double tracer technique

Gastric bypass operated subjects

12 patients, who have undergone Roux-en-Y gastric bypass \>12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age.

Diagnostic Test: Mixed meal test with double tracer technique

Interventions

Mixed meal test with double tracer techniqueDIAGNOSTIC_TEST
Control SubjectsGastric bypass operated subjectsGastric sleeve operated subjects

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation \> 12 month prior to inclusion. Matched un-operated control subjects.

You may qualify if:

  • Weight stable (+/- 3 month the last month)
  • Written informed consent

You may not qualify if:

  • Diabetes (HbA1c\>48 or Fasting plasma-glucose\>6.1 mM)
  • Pregnancy and/or breastfeeding
  • Inadequately treated thyroid disease
  • Serious heart or respiratory illness
  • Haemoglobin \< 6,5 mM.
  • Un-operated control group:
  • Written informed consent
  • Prior RYGB, SG or complicated upper gastrointestinal surgery
  • Diabetes (HbA1c\>48 or Fasting plasma-glucose\>6.1 mM)
  • Pregnancy and/or breastfeeding
  • Inadequately treated thyroid disease
  • Serious heart or respiratory illness
  • Haemoglobin \< 6,5 mM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Please Select, 2650, Denmark

Location

Related Publications (1)

  • Svane MS, Bojsen-Moller KN, Martinussen C, Dirksen C, Madsen JL, Reitelseder S, Holm L, Rehfeld JF, Kristiansen VB, van Hall G, Holst JJ, Madsbad S. Postprandial Nutrient Handling and Gastrointestinal Hormone Secretion After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy. Gastroenterology. 2019 May;156(6):1627-1641.e1. doi: 10.1053/j.gastro.2019.01.262. Epub 2019 Feb 8.

    PMID: 30742833DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples during mixed meal test with double tracer tecnique using iv tracers (\[D2\] Phenylalanine, \[ring-D4\]Tyrosine, \[6,6-2H2\]Glucose, \[1,1,2,3,3-2H5\]Glycerol, \[15N2\]Urea and labelled oral tracers (\[U13C6\]glucose, intrinsically \[ring-D5\]Phenylalanine).

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 8, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)