ObesityEarly Phase 1NCT06115304
Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
A Early Phase 1 study testing Large liquid meal, spinal catheter and venous line in people with Obesity and Diabetes Mellitus, Type 2, run by Mikkel Bring Christensen at 1 site in Denmark.
Trial summary
Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Large liquid meal, spinal catheter and venous line
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Oct 2023to 26 Aug 2024
- Phase
- Early Phase 1
- 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 male patients with obesity (BMI >30) and type 2 diabetes
- 10 male volunteers with normal weight (BMI 20-24) matched by age
- 10 male volunteers with obesity (BMI >30) matched by age
Who cannot join
- Unwillingness to participate or wish to withdraw from ongoing protocol
- Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))
- Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)
- Anaemia (p-hemoglobin below normal range)
- Nephropathy (se-creatinine >130 μM and/or albuminuria)
- Suspected difficult access to the spinal canal (e.g. pronounced scoliosis, spinal stenosis, osteoporotic coincidence in the lower back, spina bifida, meningocele after surgical intervention)
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- Lumbar skin infection (e.g. herpes zoster, pustules or ulcers)
- Medical history with headaches - both in connection with dura puncture and frequent headaches of other types
- Central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, etc.)
- Clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.)
- Patients with type 2 diabetes: Treatment with DPP-4 inhibitor or GLP-1 receptor agonist. Late diabetic complications including proliferative diabetic retinopathy (anamnestic), arteriosclerotic cardiovascular disease (heart failure or previous ischemic event/myocardial infarction)
Trial locations and contacts
1 site in 1 country.
About this study
Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. Therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. Thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals.
The purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (CSF) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Large liquid meal, spinal catheter and venous line
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large liquid meal, spinal catheter and venous lineOther
Large liquid meal (e.g. Nutricia® Energy 500 ml (750 kcal) admixed paracetamol 1000 mg (for estimation of gastric emptying) and Caffeine (to prevent postspinal headache).
Spinal catheter for 4 hours, with samples taken at one hour interval.
2 venous lines, one for saline and one for venous sampling every half hour
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | Not described Receives: Other: Large liquid meal, spinal catheter and venous line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appetite regulating hormones measured by specific immunoassays
Measured: After 1 hour
Appetite regulating hormones measured by specific immunoassays
Measured: After 2 hour
Appetite regulating hormones measured by specific immunoassays
Measured: After 3 hours
Appetite regulating hormones measured by specific immunoassays
Measured: After 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start5 Oct 2023
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mikkel Bring Christensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mikkel Bring Christensen, Bispebjerg Hospital
- Investigators
- Mikkel.bring.christensen@regionh.dk B Christensen, MD, PhD, Principal investigator, Department of clinical pharmacology, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115304
- Sponsor's protocol ID
- CSF-meal
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 23 Oct 2026
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
- ClinicalTrials.gov ID
- NCT06115304
- Acronym / sponsor ID
- CSF-meal
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mikkel Bring ChristensenUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 3 Nov 2023 (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.
Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. Therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. Thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals.
The purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (CSF) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Other: Large liquid meal, spinal catheter and venous line |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 10 male patients with obesity (BMI >30) and type 2 diabetes
- 10 male volunteers with normal weight (BMI 20-24) matched by age
- 10 male volunteers with obesity (BMI >30) matched by age
Key exclusion criteria (11 listed)
- Unwillingness to participate or wish to withdraw from ongoing protocol
- Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))
- Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)
- Anaemia (p-hemoglobin below normal range)
- Nephropathy (se-creatinine >130 μM and/or albuminuria)
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 |
|---|---|---|
| Large liquid meal, spinal catheter and venous lineLarge liquid meal (e.g. Nutricia® Energy 500 ml (750 kcal) admixed paracetamol 1000 mg (for estimation of gastric emptying) and Caffeine (to prevent postspinal headache). Spinal catheter for 4 hours, with samples taken at one hour interval. 2 venous lines, one for saline and one for venous sampling every half hour | Other | Intervention arm |
Primary outcome
Appetite regulating hormones measured by specific immunoassays
Time frame: After 1 hour
Appetite regulating hormones measured by specific immunoassays
Time frame: After 2 hour
Appetite regulating hormones measured by specific immunoassays
Time frame: After 3 hours
Appetite regulating hormones measured by specific immunoassays
Time frame: After 4 hours
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 23 Oct 2026.
- 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.
Mikkel.bring.christensen@regionh.dk B Christensen, MD, PhD principal investigator
Department of clinical pharmacology, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Large liquid meal, spinal catheter and venous line in people with Obesity and Diabetes Mellitus, Type 2, run by Mikkel Bring Christensen 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 3 inclusion and 11 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 23 Oct 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Appetite regulating hormones measured by specific immunoassays (time frame: After 1 hour). The study lists 4 primary outcomes in all. 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 23 Oct 2026.