ObesityTHE-ROSENCT04613700
The Role of Secretin on the Energy Homeostasis
A study testing Secretin in people with Obesity and Metabolic Disease, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Disease, Diabetes
- What is being tested?
- Secretin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2020to 29 Sep 2020
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Body mass index between 18.5 and 27.5 kg/m2
- Informed consent
- Body weight above 50 kg
Who cannot join
- Anaemia (blood haemoglobin below normal range)
- Known liver disease and/or alanine aminotransferase and/or aspartate transaminase > 2 times upper normal values
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
- Any physical or psychological condition that the investigators feel would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herlev- Gentofte Hospital, Center for Clinical Metabolic Research
Hellerup, Copenhagen, 2900
About this study
As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,
Read the detailed description
Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s. Secretin is produced in and secreted form small intestinal S cells. In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver. In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.
The primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.
- Conditions
- Obesity, Metabolic Disease, Diabetes, Adiposity
- Being tested
- Secretin, Placebo
- Medical subject headings
- Obesity, Metabolic Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SecretinDrug
Native hormone
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| Secretin | Active comparator | Not described Receives: Drug: Secretin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food intake on ad libitum meal
Kilojoule
Measured: 300 minutes
Duration of ad libitum meal
Duration in minutes
Measured: 300 minutes
Secondary outcomes (8)
Water intake during ad libitum meal
mL
Measured: 300 minutes
resting energy expenditure
Indirect calorimetry of respiration
Measured: Baseline, 90 minutes and 270 minutes
Supraclavicular Brown adipose activity
Evaluated by neck skin temperature assessed using a non-invasive thermal imaging camera)
Measured: -15 to 15 , 90 and 270 minutes
Appetite and satiety sensations (assessed by VASs),
Visual analogue scales with a scale of 1-10 (Direction of scale varies)
Measured: Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes
Heart rate
heart rate .
Measured: every 15 minutes from from -15 to 300 minutes
systolic blood pressure
Systolic blood pressure
Measured: every 15 minutes from from -15 to 300 minutes
Diastolic blood pressure
Diastolic blood pressures
Measured: every 15 minutes from from -15 to 300 minutes
Gallbladder motility
Gallbladder motility measured by Ultrasound
Measured: Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Mar 2020
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
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 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
- Model description
- randomised, double-blinded, placebo-controlled, cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip K Knop, Professor, MD, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613700
- Sponsor's protocol ID
- The-ROSE
- Acronym
- THE-ROSE
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heimburger SMN, Bentzen MJ, Kizilkaya HS, Hartmann B, Holst JJ, Rosenkilde MM, Dela F, Hansen SH, Rehfeld JF, Christensen MB, Knop FK. Secretin infusion decreases food intake in healthy men-a randomized, placebo-controlled, double-blind, crossover study. Eur J Endocrinol. 2024 Nov 27;191(6):545-557. doi: 10.1093/ejendo/lvae147.
PubMed 39556772
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Secretin on the Energy Homeostasis
- ClinicalTrials.gov ID
- NCT04613700
- Acronym / sponsor ID
- THE-ROSE / The-ROSE
- Conditions
- Obesity, Metabolic Disease, Diabetes, Adiposity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 3 Nov 2020 (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.
As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,
Detailed description
Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s. Secretin is produced in and secreted form small intestinal S cells. In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver. In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.
The primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomised, double-blinded, placebo-controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Secretin | Active comparator | Drug: Secretin |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- Body mass index between 18.5 and 27.5 kg/m2
- Informed consent
- Body weight above 50 kg
Key exclusion criteria (5 listed)
- Anaemia (blood haemoglobin below normal range)
- Known liver disease and/or alanine aminotransferase and/or aspartate transaminase > 2 times upper normal values
- Nephropathy (serum creatinine above normal range and/or albuminuria)
- Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
- Any physical or psychological condition that the investigators feel would interfere with trial participation
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 |
|---|---|---|
| SecretinNative hormone | Drug | Secretin |
| PlaceboSaline | Other | Placebo |
Primary outcome
Food intake on ad libitum meal
Time frame: 300 minutes
Kilojoule
Duration of ad libitum meal
Time frame: 300 minutes
Duration in minutes
8 secondary outcomes
Water intake during ad libitum meal
Time frame: 300 minutes
resting energy expenditure
Time frame: Baseline, 90 minutes and 270 minutes
Supraclavicular Brown adipose activity
Time frame: -15 to 15 , 90 and 270 minutes
Appetite and satiety sensations (assessed by VASs),
Time frame: Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes
Heart rate
Time frame: every 15 minutes from from -15 to 300 minutes
systolic blood pressure
Time frame: every 15 minutes from from -15 to 300 minutes
Diastolic blood pressure
Time frame: every 15 minutes from from -15 to 300 minutes
Gallbladder motility
Time frame: Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 39556772Heimburger SMN, Bentzen MJ, Kizilkaya HS, Hartmann B, Holst JJ, Rosenkilde MM, Dela F, Hansen SH, Rehfeld JF, Christensen MB, Knop FK. Secretin infusion decreases food intake in healthy men-a randomized, placebo-controlled, double-blind, crossover study. Eur J Endocrinol. 2024 Nov 27;191(6):545-557. doi: 10.1093/ejendo/lvae147.
- Individual participant dataSharing planned: No
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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.
Filip K Knop, Professor, MD principal investigator
Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secretin in people with Obesity and Metabolic Disease, run by Steno Diabetes Center Copenhagen 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food intake on ad libitum meal (time frame: 300 minutes). The study lists 2 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 NCT04613700, 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 5 Nov 2020.