Fat Metabolites and Gut Hormones

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03223389
• Collaborator: University of Copenhagen (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.8
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Type 2 Diabetes; Bariatric Surgery; Gut Hormones; Dietary Fat	Dietary Supplement: C-8 dietary oil; Dietary Supplement: Tricaprylin; Dietary Supplement: Olive oil	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery
• Anticipated Study Start Date: Aug 7, 2017
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. Responses (evaluated by AUC above basal) of insulin within and between groups. [0-240 min following fat ingestion.]

5. Responses (evaluated by AUC above basal) of C-peptide within and between groups. [0-240 min following fat ingestion.]

6. Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups. [0-240 min following fat ingestion.]

7. Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups. [0-240 min following fat ingestion.]

8. Responses (evaluated by AUC above basal) of glucagon within and between groups. [0-240 min following fat ingestion.]

9. Responses (evaluated by AUC above basal) of bile acids within and between groups. [0-240 min following fat ingestion.]

10. Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups. [0-240 min following fat ingestion.]

11. Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups. [0-240 min following fat ingestion.]

12. Responses (evaluated by AUC above basal) of neurotensin within and between groups. [0-240 min following fat ingestion.]

13. Responses (evaluated by AUC above basal) of glucose within and between groups. [0-240 min following fat ingestion.]

14. 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.

15. 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.

16. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Endocrinology	Hvidovre		Denmark	2650

Sponsors and Collaborators

• Hvidovre University Hospital
• University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christoffer Martinussen, Medical doctor, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT03223389
• Other Study ID Numbers: CM-FAT-17
• First Posted: Jul 21, 2017
• Last Update Posted: Jul 26, 2017
• Last Verified: Jul 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jul 26, 2017