Fat Metabolites and Gut Hormones

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

Detailed Description
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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.

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

Conditions
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Gut Hormones, Overweight and Obesity, Type 2 Diabetes, Bariatric Surgery, Dietary Fat

Intervention / Treatment
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* Dietary Supplement: C-8 dietary oil
* Dietary Supplement: Tricaprylin
* Dietary Supplement: Olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. |