Fat Metabolites and Gut Hormones

Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery

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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes; Overweight and Obesity; Bariatric Surgery; Dietary Fat; Gut Hormones
• Intervention / Treatment: Dietary supplement: C-8 dietary oil; Dietary supplement: Tricaprylin; Dietary supplement: Olive oil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Dept. of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 gastric bypass operated patients; 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 oil; Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.; Dietary supplement: Tricaprylin; Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.; Dietary supplement: Olive oil; Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.
Experimental: 10 healthy control subjects; 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 oil; Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.; Dietary supplement: Tricaprylin; Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.; Dietary supplement: Olive oil; Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-240 min following fat ingestion.
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.	0-240 min following fat ingestion.
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.	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.
Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucagon within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of bile acids within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of neurotensin within and between groups.		0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucose within and between groups.		0-240 min following fat ingestion.
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.	0-240 min following fat ingestion.
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.	0-240 min following fat ingestion.
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.	0-240 min following fat ingestion.

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 7, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: CM-FAT-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No