Metabolic SyndromeNCT03061227
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge
A study testing Intravenous glucagon and Intravenous saline in people with Metabolic Syndrome and Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. This phenotype is associated with healthy metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes
- What is being tested?
- Intravenous glucagon and Intravenous saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 10 Feb 2017to 30 Apr 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5- 29.9 kg/m2
- written informed consent
Who cannot join
- Current
- febrile infection with temperatures> 38.5 ° C in the last 14 days
- Blood donation within the last 12 weeks Pre-study Inclusion
- Chronic diseases:
- Diabetes mellitus
- Known liver diseases (hepatitisB/C, hemochromatosis, NASH)
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- Chronic inflammatory diseases (rheumatoid arthritis, Crohn's disease, ulcerative colitis) chronic renal insufficiency
- Cancer (known malignant disease)
- psychiatric diagnoses (bipolar disorder, schizophrenia, psychoses, depression, agoraphobia)
- Persons with non-removable metal parts, e.g:
- pacemaker
- artificial heart valves
- metal prostheses
- implanted magnetic metal parts (screws, plates of operations)
- spiral
- metal slivers / garnet splinters
- fixed braces
- Acupuncture needle
- Insulin pump
- totally implantable venous access device (port)
- tattoos, metallic eye shadows
- Persons with impaired sensitivity and / or increased sensitivity to heating of the body
- Medical history of venous thromboembolism
- alcohol consumption of more than 50g / day
- In physical examination:
- blood pressure > 160/100 mmHg pathologic cardiac murmurs (diastolic or systolic louder than 2/6)
- in the blood test: fasting glucose ≥ 125 mg/dl or HbA1c ≥ 6.5% AST or ALT> 2.5x upper limit of the reference range (> 125 U/l) Hb <12 g/dl C reactive protein (CRP) > 5 mg / dL or leukocytes> 15000/μl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic and Central Nervous System Characterisation of the Phenotype of Non-suppressed (Rising) Glucagon After Glucose Challenge
The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. This phenotype is associated with healthy metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content. Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous glucose production, also reduces appetite and increases basal energy expenditure. The aims of this study are to i. detect functional differences in the appetite-related central nervous system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick the non-suppressed glucagon phenotype in those participants who suppress glucagon by administering a very-low-dose glucagon infusion and retest them.
- Conditions
- Metabolic Syndrome, Diabetes
- Being tested
- Intravenous glucagon, Intravenous saline
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous glucagonDrug
Randomized application of glucagon or saline during oral glucose tolerance test
Intravenous salineDrug
Randomized application of glucagon or saline during oral glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| Intravenous glucagon | Active comparator | Low-dose glucagon infusion (0.5 pmol/min/kg body weight) over 150 minutes during a standardized 75 g oral glucose tolerance test Receives: Drug: Intravenous glucagon |
| Intravenous saline | Placebo comparator | Saline infusion over 150 minutes during a standardized 75 g oral glucose tolerance test Receives: Drug: Intravenous saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity
Resting-state brain activity assessed by fMRI
Measured: change from baseline to 120 minutes after oral glucose challenge
Secondary outcomes (6)
Hunger rating
On visual analogue scale
Measured: before and 150 minutes after oral glucose challenge and start of glucagon/saline infusion
Brain response to food cues
Assessed by functional magnetic resonance imaging (fMRI)
Measured: before, 30 minutes and 120 minutes after oral glucose challenge and start of glucagon/saline infusion
Glucose tolerance
Assessed by 75 g oral glucose tolerance test
Measured: 0-120 minutes
Insulin sensitivity
Assessed during 75 g oral glucose tolerance test
Measured: 0-120 minutes
Basal energy expenditure
Assessed by indirect calorimetry
Measured: 150 minutes after oral glucose challenge
Change in hormone levels
Change in adrenocorticotropic hormone (ACTH), growth hormone (GH), thyroid-stimulating hormone (TSH), luteinizing hormone (LH), follicle stimulating hormone (FSH), fibroblast growth factor 21(FGF-21) after oral glucose challenge and start of glucagon/saline infusion.
Measured: 0-150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start10 Feb 2017
- Primary completion17 Jan 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061227
- Sponsor's protocol ID
- 529_2016BO1
- Status last verified
- Apr 2020
- First submitted
- 9 Feb 2017
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Central Nervous System Characterisation of the Phenotype of Non-suppressed (Rising) Glucagon After Glucose Challenge
- ClinicalTrials.gov ID
- NCT03061227
- Acronym / sponsor ID
- 529_2016BO1
- Conditions
- Metabolic Syndrome, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 23 Feb 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.
The investigators previously characterized a phenotype with non-suppressed glucagon at 120 minutes after standardized oral glucose load. This phenotype is associated with healthy metabolic traits such as lower BMI, higher insulin sensitivity and lower liver fat content. Glucagon is a pleiotropic hormone that, besides its main action on increasing endogenous glucose production, also reduces appetite and increases basal energy expenditure. The aims of this study are to i. detect functional differences in the appetite-related central nervous system (CNS) areas between the suppressed and non-suppressed glucagon phenotype ii. mimick the non-suppressed glucagon phenotype in those participants who suppress glucagon by administering a very-low-dose glucagon infusion and retest them.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous glucagon | Active comparator | Drug: Intravenous glucagonLow-dose glucagon infusion (0.5 pmol/min/kg body weight) over 150 minutes during a standardized 75 g oral glucose tolerance test |
| Intravenous saline | Placebo comparator | Drug: Intravenous salineSaline infusion over 150 minutes during a standardized 75 g oral glucose tolerance test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 18.5- 29.9 kg/m2
- written informed consent
Key exclusion criteria (27 listed)
- Current
- Chronic diseases:
- blood pressure > 160/100 mmHg pathologic cardiac murmurs (diastolic or systolic louder than 2/6)
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 |
|---|---|---|
| Intravenous glucagonRandomized application of glucagon or saline during oral glucose tolerance test | Drug | Intravenous glucagon |
| Intravenous salineRandomized application of glucagon or saline during oral glucose tolerance test | Drug | Intravenous saline |
Primary outcome
Brain activity
Time frame: change from baseline to 120 minutes after oral glucose challenge
Resting-state brain activity assessed by fMRI
6 secondary outcomes
Hunger rating
Time frame: before and 150 minutes after oral glucose challenge and start of glucagon/saline infusion
Brain response to food cues
Time frame: before, 30 minutes and 120 minutes after oral glucose challenge and start of glucagon/saline infusion
Glucose tolerance
Time frame: 0-120 minutes
Insulin sensitivity
Time frame: 0-120 minutes
Basal energy expenditure
Time frame: 150 minutes after oral glucose challenge
Change in hormone levels
Time frame: 0-150 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 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous glucagon and Intravenous saline in people with Metabolic Syndrome and Diabetes, run by University Hospital Tuebingen at 1 site in Germany.
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 2 inclusion and 27 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 May 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 Germany. 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?
Brain activity (time frame: change from baseline to 120 minutes after oral glucose challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2020.