Clinical trial NCT03223389: Fat Metabolites and Gut Hormones
Official title: Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Type 2 Diabetes
Bariatric Surgery
Gut Hormones
Dietary Fat
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2017-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Within group difference in Gastric Inhibitory Peptide (GIP) secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Within group difference in cholecystokinin (CCK) secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
Secondary outcomes:
measure: Between group comparison of GLP-1 secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Between group comparison of GIP secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Between group comparison of CCK secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of insulin within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of C-peptide within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of glucagon within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of bile acids within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of neurotensin within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Responses (evaluated by AUC above basal) of glucose within and between groups.
timeFrame: 0-240 min following fat ingestion.
measure: Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Between group comparison of differences in GIP secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
measure: Between group comparison of differences in CCK secretion (evaluated by AUC above basal).
timeFrame: 0-240 min following fat ingestion.
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Endocrinology
Study officials:
References:
citation: 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.