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Fat Metabolites and Gut Hormones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223389
Recruitment Status : Unknown
Verified July 2017 by Christoffer Martinussen, Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2017
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Christoffer Martinussen, 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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 7, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.




Primary Outcome Measures :
  1. Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: 0-240 min following fat ingestion. ]
  5. Responses (evaluated by AUC above basal) of C-peptide within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  6. Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  7. Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  8. Responses (evaluated by AUC above basal) of glucagon within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  9. Responses (evaluated by AUC above basal) of bile acids within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  10. Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  11. Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  12. Responses (evaluated by AUC above basal) of neurotensin within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  13. Responses (evaluated by AUC above basal) of glucose within and between groups. [ Time Frame: 0-240 min following fat ingestion. ]
  14. Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal). [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223389


Contacts
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Contact: Sten Madsbad, Professor +4538623032 sten.madsbad@regionh.dk

Locations
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Denmark
Dept. of Endocrinology
Hvidovre, Denmark, 2650
Contact: Christoffer Martinussen, MD    +4538623032    christoffer.martinussen@regionh.dk   
Principal Investigator: Christoffer Martinussen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christoffer Martinussen, Medical doctor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03223389    
Other Study ID Numbers: CM-FAT-17
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

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