Overweight and ObesityNCT03223389
Fat Metabolites and Gut Hormones
A study testing C-8 dietary oil, Tricaprylin and Olive oil in people with Overweight and Obesity and Type 2 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Type 2 Diabetes, Bariatric Surgery
- What is being tested?
- C-8 dietary oil, Tricaprylin and Olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Aug 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Uncomplicated gastric bypass surgery performed minimum 12 months prior to study
Who cannot join
- 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:
- Bariatric surgery or complicated upper abdominal surgery
Show all 10Show fewer
- Gall bladder removal
- Pregnancy or breastfeeding
- Haemoglobin levels below 6,5 mM
- Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Endocrinology
Hvidovre, 2650
Christoffer Martinussen, MD, +4538623032, christoffer.martinussen@regionh.dk
Christoffer Martinussen, MD
About this study
Official title: Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery
To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.
Read the 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.
- Being tested
- C-8 dietary oil, Tricaprylin, Olive oil
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-8 dietary oilDietary supplement
Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.
TricaprylinDietary supplement
Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.
Olive oilDietary supplement
Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.
| Study group | Role | What they receive |
|---|---|---|
| 10 gastric bypass operated patients | Experimental | 3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion. Receives: Dietary Supplement: C-8 dietary oil; Dietary Supplement: Tricaprylin; Dietary Supplement: Olive oil |
| 10 healthy control subjects | Experimental | 3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion. Receives: Dietary Supplement: C-8 dietary oil; Dietary Supplement: Tricaprylin; Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-240 min following fat ingestion.
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of insulin within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of C-peptide within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucagon within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of bile acids within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of fibroblast growth factor 19 (FGF-19) within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of lipid metabolites (triglyceride, cholesterol, fatty acids) within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of neurotensin within and between groups.
Measured: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucose within and between groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-240 min following fat ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start7 Aug 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Christoffer Martinussen, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223389
- Sponsor's protocol ID
- CM-FAT-17
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31742316
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fat Metabolites on Gut Hormone Secretion After Gastric Bypass Surgery
- ClinicalTrials.gov ID
- NCT03223389
- Acronym / sponsor ID
- CM-FAT-17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 7 Aug 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 gastric bypass operated patients | Experimental | Dietary Supplement: C-8 dietary oil, Dietary Supplement: Tricaprylin, Dietary Supplement: Olive oil3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion. |
| 10 healthy control subjects | Experimental | Dietary Supplement: C-8 dietary oil, Dietary Supplement: Tricaprylin, Dietary Supplement: Olive oil3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Uncomplicated gastric bypass surgery performed minimum 12 months prior to study
Key exclusion criteria (10 listed)
- 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
- Bariatric surgery or complicated upper abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-8 dietary oilIngestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides. | Dietary supplement | 10 gastric bypass operated patients, 10 healthy control subjects |
| TricaprylinIngestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides. | Dietary supplement | 10 gastric bypass operated patients, 10 healthy control subjects |
| Olive oilIngestion of 19 g olive oil providing 0.0216 mol of triglycerides. | Dietary supplement | 10 gastric bypass operated patients, 10 healthy control subjects |
Primary outcome
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.
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.
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.
16 secondary outcomes
Between group comparison of GLP-1 secretion (evaluated by AUC above basal).
Time frame: 0-240 min following fat ingestion.
Between group comparison of GIP secretion (evaluated by AUC above basal).
Time frame: 0-240 min following fat ingestion.
Between group comparison of CCK secretion (evaluated by AUC above basal).
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of insulin within and between groups.
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of C-peptide within and between groups.
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of peptide YY (PYY) within and between groups.
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of oxyntomodulin within and between groups.
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucagon within and between groups.
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of bile acids within and between groups.
Time frame: 0-240 min following fat ingestion.
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.
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.
Responses (evaluated by AUC above basal) of neurotensin within and between groups.
Time frame: 0-240 min following fat ingestion.
Responses (evaluated by AUC above basal) of glucose within and between groups.
Time frame: 0-240 min following fat ingestion.
Between group comparison of differences in GLP-1 secretion (evaluated by AUC above basal).
Time frame: 0-240 min following fat ingestion.
Between group comparison of differences in GIP secretion (evaluated by AUC above basal).
Time frame: 0-240 min following fat ingestion.
Between group comparison of differences in CCK secretion (evaluated by AUC above basal).
Time frame: 0-240 min following fat ingestion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Derived from this study: PubMed 31742316Martinussen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-8 dietary oil, Tricaprylin and Olive oil in people with Overweight and Obesity and Type 2 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sten Madsbad, Professor (+4538623032, sten.madsbad@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within group difference in glucagon-like peptide-1 (GLP-1) secretion (evaluated by AUC above basal). (time frame: 0-240 min following fat ingestion.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.