NCT03223389

Brief Summary

To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

August 7, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

July 18, 2017

Last Update Submit

July 24, 2017

Conditions

Overweight and ObesityType 2 DiabetesBariatric SurgeryGut HormonesDietary Fat

Outcome Measures

Primary Outcomes (3)

  • Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal).

    Comparison of the GLP-1 responses (evaluated by AUC above basal) induced by the different oils.

    0-240 min following fat ingestion.

  • Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).

    Comparison of the GIP responses (evaluated by AUC above basal) induced by the different oils.

    0-240 min following fat ingestion.

  • Within group difference in cholecystokinin (CCK) secretion (evaluated by AUC above basal).

    Comparison of the CCK responses (evaluated by AUC above basal) induced by the different oils.

    0-240 min following fat ingestion.

Secondary Outcomes (16)

  • Between group comparison of GLP-1 secretion (evaluated by AUC above basal).

    0-240 min following fat ingestion.

  • Between group comparison of GIP secretion (evaluated by AUC above basal).

    0-240 min following fat ingestion.

  • Between group comparison of CCK secretion (evaluated by AUC above basal).

    0-240 min following fat ingestion.

  • Responses (evaluated by AUC above basal) of insulin within and between groups.

    0-240 min following fat ingestion.

  • Responses (evaluated by AUC above basal) of C-peptide within and between groups.

    0-240 min following fat ingestion.

  • +11 more secondary outcomes

Study Arms (2)

10 gastric bypass operated patients

EXPERIMENTAL

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

Dietary Supplement: C-8 dietary oilDietary Supplement: TricaprylinDietary Supplement: Olive oil

10 healthy control subjects

EXPERIMENTAL

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

Dietary Supplement: C-8 dietary oilDietary Supplement: TricaprylinDietary Supplement: Olive oil

Interventions

C-8 dietary oilDIETARY_SUPPLEMENT

Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.

10 gastric bypass operated patients10 healthy control subjects
TricaprylinDIETARY_SUPPLEMENT

Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.

10 gastric bypass operated patients10 healthy control subjects
Olive oilDIETARY_SUPPLEMENT

Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

10 gastric bypass operated patients10 healthy control subjects

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

You may not qualify if:

  • Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Gall bladder removal
  • Healthy control subjects:
  • Bariatric surgery or complicated upper abdominal surgery
  • Gall bladder removal
  • Pregnancy or breastfeeding
  • Haemoglobin levels below 6,5 mM
  • Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Endocrinology

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Martinussen C, Dirksen C, Bojsen-Moller KN, Svane MS, Carlsson ER, Hartmann B, Clausen TR, Veedfald S, Kristiansen VB, Rehfeld JF, Hansen HS, Holst JJ, Madsbad S. Intestinal sensing and handling of dietary lipids in gastric bypass-operated patients and matched controls. Am J Clin Nutr. 2020 Jan 1;111(1):28-41. doi: 10.1093/ajcn/nqz272.

    PMID: 31742316DERIVED

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2

Interventions

tricaprylinOlive Oil

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Sten Madsbad, Professor

CONTACT

+4538623032sten.madsbad@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

August 7, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

DK(1)