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HealthyNCT03543423

Studies of the Early Meal Phase in Healthy Individuals - Nutrient Absorption and Gastrointestinal Hormone Secretion

A study testing Oral glucose tolerance test and Liquid mixed meal test in people with Healthy, run by University of Copenhagen at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Oral glucose tolerance test and Liquid mixed meal test
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteDenmark
Study dates
1 Jun 2018to 30 Jun 2019
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 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 18 and 40years
  • Male
  • Normal Haemoglobin concentration
  • Informed consent

Who cannot join

  • Diabetes mellitus
  • Family history of diabetes mellitus
  • intestinal disease (for example inflammatory bowel disease or malabsorption)
  • Family history of inflammatory bowel disease
  • Previous intestinal resection (except uncomplicated appendicectomy)
  • Body mass index (BMI) > 25 kg/m2
Show all 15Show fewer
  • Tobacco use
  • kidney disease (se-creatinine> 130 µM and/or albuminuria)
  • liver disease (ALAT and/or ASAT >2 × above normal range)
  • Heart disease
  • Treatment with drugs
  • History of constipation
  • Conditions with delayed or accelerated gastric emptying
  • Latex or other allergies
  • Bleeding diathesis

Trial locations and contacts

1 site in 1 country.

Simon Veedfald, MD contact

+45 41102595

veedfald@sund.ku.dk

Jens J Holst, DMSCI contact

jjholst@sund.ku.dk

Denmark1 site, 1 recruiting

  • Department of Gastrointestinal Surgery, Righospitalet

    Copenhagen, Capital, 2100

    Lars Bo Svendsen, DMSci, lars.bo.svendsen@regionh.dk

    Simon Veedfald, MD, +4541102595, Simon.veedfald@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: Studier af Den Tidlige Måltidsfase i Raske Individer

To investigate gastrointestinal hormone secretions and nutrient absorption during the early meal phase we will recruit 12 healthy young men. They will be equipped with peripheral intravenous catheters for frequent blood sampling. Participants will be screened and acclimatised to the study situation on visit 1. On visit 2 and 3 participants will in random order ingest an oral glucose solution or a standardised liquid mixed meal over 2-3 min.

Conditions
Healthy
Being tested
Oral glucose tolerance test, Liquid mixed meal test
Keywords
Gut hormone secretion, Glucose absorption, early meal phase, Insulin and glucagon secretion
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral glucose tolerance testOther

    Oral glucose tolerance test will be carried out with a glucose solution made up of 75g glucose dissolved in 300mL. To the glucose solution will be added 5g 3-OMG and 1g paracetamol 5g 3-OMG

  • Liquid mixed meal testOther

    A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).

Study groups in NCT03543423
Study groupRoleWhat they receive
Oral glucose tolerance testExperimentalIntervention: oral glucose tolerance test (75 gram glucose supplemented with 5g 3-OMG and 1g paracetamol) ingested over 2 min.
Receives: Other: Oral glucose tolerance test
Liquid mixed meal testExperimentalIntervention: Standardised liquid mixed meal (supplemented with 1g paracetamol) ingested over 2min
Receives: Other: Liquid mixed meal test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma GIP concentrations

    Glucose-dependent insulinotropic polypeptide plasma concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

Secondary outcomes (12)

  1. Plasma GLP-1 concentrations

    Glucagon-like peptide-1 plasma concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  2. Serum 3-OMG concentrations

    Serum 3-OMG concentrations (glucose absorption marker)

    Measured: -10, -2, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30

  3. Serum C-peptide and insulin concentrations

    Glucagon-like peptide-1 plasma concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  4. Plasma gastrin concentrations

    Plasma gastrin concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  5. Plasma CCK concentrations

    Plasma cholecystokinin concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  6. Plasma PP concentrations

    Plasma pancreatic polypeptide concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  7. Plasma NT concentrations

    Plasma Neurotensin concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  8. Plasma glucagon concentrations

    Plasma glucagon concentrations

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  9. Serum 3-OMG concentrations

    Serum 3-OMG concentrations (glucose absorption marker)

    Measured: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  10. Plasma acetaminophen

    Plasma acetaminophen (as a measure of gastric emptying)

    Measured: -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  11. Plasma amino acids

    Plasma amino acids

    Measured: -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

  12. Plasma bile acids

    Plasma bile acids

    Measured: -10, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2018
  2. Study start1 Jun 2018 (estimated)
  3. Primary completion30 Sep 2018 (estimated)
  4. Study completion30 Jun 2019 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Model description
12 healthy male individuals will each be studied on two occasions in random order. * oral glucose tolerance test * liquid mixed meal test
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03543423
Sponsor's protocol ID
UC/RH-early phase
Status last verified
May 2018
First submitted
20 May 2018
Last updated
1 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Veedfald S, Rehfeld JF, van Hall G, Svendsen LB, Holst JJ. Entero-Pancreatic Hormone Secretion, Gastric Emptying, and Glucose Absorption After Frequently Sampled Meal Tests. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e188-e204. doi: 10.1210/clinem/dgab610.

    PubMed 34479362

Questions about this trial

What is this clinical trial studying?

A study testing Oral glucose tolerance test and Liquid mixed meal test in people with Healthy, run by University of 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 15 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 1 Jun 2018. 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 Simon Veedfald, MD (+45 41102595, veedfald@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma GIP concentrations (time frame: -40, -20, -18, -16, -14, -12, -10, -8, -6, -4, -2, 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 30 min). 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 NCT03543423, 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 1 Jun 2018.

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