NCT02372526

Brief Summary

The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.

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
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

February 20, 2015

Last Update Submit

February 6, 2017

Conditions

Bariatric Surgery (Gastric Bypass)Overweight

Keywords

Glucagon-like Peptide-1Glucose-dependent insulinotropic peptideGlucagonPeptide YY 3-36GhrelinBody WeightObesityOvernutritionOverweightGastrointestinal AgentsGLP-1 secretagogue

Outcome Measures

Primary Outcomes (1)

  • Within group difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).

    I.e. Comparison of GLP-1 secretion (iAUC) as a result of intake of different macronutrients between a) gastric bypass patients only b) healthy volunteers only.

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

Secondary Outcomes (13)

  • Within group difference in Glucagon secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • Within group difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • Within group difference in Cholecystokinin secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • Within group difference in Peptide YY 3-36 secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • Within group difference in Ghrelin secretion (evaluated by iAUC).

    0, 30, 45, 60, 120, 180, 240

  • +8 more secondary outcomes

Other Outcomes (14)

  • Between groups difference in Glucagon-like Peptide 1 secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • Between groups difference in Glucagon secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • Between groups difference in Glucose-dependent insulinotropic peptide secretion (evaluated by iAUC).

    Basline, 0, 15, 30, 45, 60, 90, 120, 180, 240

  • +11 more other outcomes

Study Arms (2)

10 Roux-en-Y gastric bypass patients

Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation.

Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutesOther: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutesOther: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutesOther: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

10 Healthy Control subjects

Isocaloric amounts of specific macronutrients is mixed with 4 g vegetable bouillon and tested against each others ability to induce GLP-1 secretion. The mealtest takes place at 4 different days with 3-14 days separation.

Other: Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutesOther: Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutesOther: Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutesOther: Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes

Interventions

Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutesOTHER
Also known as: LACPRODAN SP-9225 INSTANT Whey Protein Isolate
10 Healthy Control subjects10 Roux-en-Y gastric bypass patients
Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutesOTHER
Also known as: Lurpak® smør(butter) 81% fat
10 Healthy Control subjects10 Roux-en-Y gastric bypass patients
Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutesOTHER
Also known as: Urtegaarden Druesukker (Dextrose monohydrat)
10 Healthy Control subjects10 Roux-en-Y gastric bypass patients
Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutesOTHER
Also known as: Lurpak® smør(butter) 81% fat with 120 mg Xenical® Orlistat
10 Healthy Control subjects10 Roux-en-Y gastric bypass patients

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

RYGB Patients who have underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month). Healthy control subjects who have not underwent bariatric surgery.

You may qualify if:

  • Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)

You may not qualify if:

  • Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
  • Healthy control subjects:
  • Have not underwent bariatric surgery.
  • Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endocrinology Research Center, Hvidovre University Hospital

Hvidovre, Copenhagen, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum.

MeSH Terms

Conditions

OverweightBody WeightObesityOvernutrition

Interventions

CD36 Antigens

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Design

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

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

June 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

DK(1)