Fat Metabolites and Gut Hormones

Not Applicable

• Conditions: Dietary Fat; Type 2 Diabetes; Gut Hormones; Overweight and Obesity; Bariatric Surgery
• Interventions: Dietary Supplement: C-8 dietary oil; Dietary Supplement: Tricaprylin; Dietary Supplement: Olive oil

• Registration Number: NCT03223389
• Lead Sponsor: Hvidovre University Hospital

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.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26
• Study Start: 2017-08-07
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10 gastric bypass operated patients	Tricaprylin	3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
10 healthy control subjects	C-8 dietary oil	3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
10 healthy control subjects	Olive oil	3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
10 gastric bypass operated patients	C-8 dietary oil	3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
10 gastric bypass operated patients	Olive oil	3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.
10 healthy control subjects	Tricaprylin	3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

Primary Outcome Measures

Name	Time	Method
Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).	0-240 min following fat ingestion.	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).	0-240 min following fat ingestion.	Comparison of the CCK responses (evaluated by AUC above basal) induced by the different oils.
Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal).	0-240 min following fat ingestion.	Comparison of the GLP-1 responses (evaluated by AUC above basal) induced by the different oils.

Secondary Outcome Measures

Name	Time	Method
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 fibroblast growth factor 19 (FGF-19) 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 glucagon 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.
Between group comparison of GLP-1 secretion (evaluated by AUC above basal).	0-240 min following fat ingestion.	GLP-1 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 bile acids 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 CCK secretion (evaluated by AUC above basal).	0-240 min following fat ingestion.	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.
Between group comparison of GIP secretion (evaluated by AUC above basal).	0-240 min following fat ingestion.	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).	0-240 min following fat ingestion.	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.	0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.	0-240 min following fat ingestion.
Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).	0-240 min following fat ingestion.	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).	0-240 min following fat ingestion.	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.

Trial Locations

Locations (1)

Dept. of Endocrinology; 🇩🇰 Hvidovre, Denmark