Fat Metabolites and Gut Hormones

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03223389
• Other study ID #: CM-FAT-17
• Status: Not yet recruiting
• Phase: N/A
• First received: July 18, 2017
• Last updated: July 24, 2017
• Start date: August 7, 2017
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Hvidovre University Hospital
• Contact: Sten Madsbad, Professor
• Phone: +4538623032
• Email: sten.madsbad[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• C-8 dietary oil
Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.
• Tricaprylin
Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.
• Olive oil
Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

Locations

Country	Name	City	State
Denmark	Dept. of Endocrinology	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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