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Fat Metabolites and Gut Hormones

Primary Purpose

Overweight and Obesity, Type 2 Diabetes, Bariatric Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
C-8 dietary oil
Tricaprylin
Olive oil
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight and Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Gastric bypass operated patients:

Inclusion Criteria:

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

Exclusion Criteria:

  • 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:

Exclusion Criteria:

  • 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

Sites / Locations

  • Dept. of Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

10 gastric bypass operated patients

10 healthy control subjects

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Between group comparison of GLP-1 secretion (evaluated by AUC above basal).
GLP-1 secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
Between group comparison of GIP secretion (evaluated by AUC above basal).
GIP secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
Between group comparison of CCK secretion (evaluated by AUC above basal).
GIP secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
Responses (evaluated by AUC above basal) of insulin within and between groups.
Responses (evaluated by AUC above basal) of C-peptide within and between groups.
Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.
Responses (evaluated by AUC above basal) of glucagon within and between groups.
Responses (evaluated by AUC above basal) of bile acids within and between groups.
Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.
Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.
Responses (evaluated by AUC above basal) of neurotensin within and between groups.
Responses (evaluated by AUC above basal) of glucose within and between groups.
Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).
Differences in GLP-1 secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
Between group comparison of differences in GIP secretion (evaluated by AUC above basal).
Differences in GIP secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
Between group comparison of differences in CCK secretion (evaluated by AUC above basal).
Differences in CCK secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.

Full Information

First Posted
July 18, 2017
Last Updated
July 24, 2017
Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03223389
Brief Title
Fat Metabolites and Gut Hormones
Official Title
Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2017 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.
Detailed Description
Dietary triglycerides are hydrolyzed during digestion to two fatty acids and one 2-monoacyl glycerol. The study will investigate the effects of these different fat components on gut hormone secretion in gastric bypass operated patients and non-operated BMI-matched controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Type 2 Diabetes, Bariatric Surgery, Gut Hormones, Dietary Fat

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 gastric bypass operated patients
Arm Type
Experimental
Arm Description
3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
Arm Title
10 healthy control subjects
Arm Type
Experimental
Arm Description
3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
Intervention Type
Dietary Supplement
Intervention Name(s)
C-8 dietary oil
Intervention Description
Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.
Intervention Type
Dietary Supplement
Intervention Name(s)
Tricaprylin
Intervention Description
Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.
Primary Outcome Measure Information:
Title
Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal).
Description
Comparison of the GLP-1 responses (evaluated by AUC above basal) induced by the different oils.
Time Frame
0-240 min following fat ingestion.
Title
Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).
Description
Comparison of the GIP responses (evaluated by AUC above basal) induced by the different oils.
Time Frame
0-240 min following fat ingestion.
Title
Within group difference in cholecystokinin (CCK) secretion (evaluated by AUC above basal).
Description
Comparison of the CCK responses (evaluated by AUC above basal) induced by the different oils.
Time Frame
0-240 min following fat ingestion.
Secondary Outcome Measure Information:
Title
Between group comparison of GLP-1 secretion (evaluated by AUC above basal).
Description
GLP-1 secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
Time Frame
0-240 min following fat ingestion.
Title
Between group comparison of GIP secretion (evaluated by AUC above basal).
Description
GIP secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
Time Frame
0-240 min following fat ingestion.
Title
Between group comparison of CCK secretion (evaluated by AUC above basal).
Description
GIP secretion (evaluated by AUC above basal) in gastric bypass operated patients compared to BMI-matched control subjects for each of the oils.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of insulin within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of C-peptide within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of glucagon within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of bile acids within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of neurotensin within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Responses (evaluated by AUC above basal) of glucose within and between groups.
Time Frame
0-240 min following fat ingestion.
Title
Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).
Description
Differences in GLP-1 secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
Time Frame
0-240 min following fat ingestion.
Title
Between group comparison of differences in GIP secretion (evaluated by AUC above basal).
Description
Differences in GIP secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
Time Frame
0-240 min following fat ingestion.
Title
Between group comparison of differences in CCK secretion (evaluated by AUC above basal).
Description
Differences in CCK secretion (evaluated by AUC above basal) induced by the different oils in gastric bypass operated patients compared with differences in BMI-matched control subjects.
Time Frame
0-240 min following fat ingestion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Gastric bypass operated patients: Inclusion Criteria: Uncomplicated gastric bypass surgery performed minimum 12 months prior to study Exclusion Criteria: 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: Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sten Madsbad, Professor
Phone
+4538623032
Email
sten.madsbad@regionh.dk
Facility Information:
Facility Name
Dept. of Endocrinology
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoffer Martinussen, MD
Phone
+4538623032
Email
christoffer.martinussen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Christoffer Martinussen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31742316
Citation
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.
Results Reference
derived

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Fat Metabolites and Gut Hormones

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