Endocrine System DiseasesNCT01875575
Oral Glucose Stimulation in Normal-weight and Obese Volunteers
A study testing Glucose 25g and Glucose 10g in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in normal-weight and obese patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine System Diseases
- What is being tested?
- Glucose 25g and Glucose 10g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Apr 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy normal weight subjects with a body-mass index of 19.0-24.5 or healthy obese subjects with a body-mass index of > 30
- Normal eating habits
- Age 18-40 years
- Stable body weight for at least three months
Who cannot join
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- Any abnormality detected during the screening procedure
- history of gastrointestinal disorders
- food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Glucose in Normal-weight and Obese Volunteers
The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in normal-weight and obese patients.
- Conditions
- Endocrine System Diseases
- Being tested
- Placebo, Glucose 25g, Glucose 10g
- Keywords
- glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Glucose 25gDietary supplement
Glucose 10gDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Glucose 10g | Active comparator | 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube Receives: Dietary Supplement: Glucose 10g |
| Glucose 25g | Active comparator | 25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube Receives: Dietary Supplement: Glucose 25g |
| Placebo | Placebo comparator | intragastric tap water Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of different oral glucose loads on secretion of satiation hormones
Plasma concentrations of glucose, insulin, glucagon, ghrelin, GLP-1, PYY and CCK are measured
Measured: 240min.
Secondary outcomes (1)
Effect of different oral glucose loads on gastric emptying
measured by C13 breath test
Measured: 240min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 2013
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 Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, Prof, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875575
- Sponsor's protocol ID
- EKBB 08/11
- Status last verified
- Jun 2013
- First submitted
- 8 May 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyer-Gerspach AC, Cajacob L, Riva D, Herzog R, Drewe J, Beglinger C, Wolnerhanssen BK. Mechanisms Regulating Insulin Response to Intragastric Glucose in Lean and Non-Diabetic Obese Subjects: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Mar 4;11(3):e0150803. doi: 10.1371/journal.pone.0150803. eCollection 2016.
PubMed 26942445
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glucose in Normal-weight and Obese Volunteers
- ClinicalTrials.gov ID
- NCT01875575
- Acronym / sponsor ID
- EKBB 08/11
- Conditions
- Endocrine System Diseases
- Keywords
- glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jun 2013 (estimated)
- 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 objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in normal-weight and obese patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose 10g | Active comparator | Dietary Supplement: Glucose 10g10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube |
| Glucose 25g | Active comparator | Dietary Supplement: Glucose 25g25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube |
| Placebo | Placebo comparator | Dietary Supplement: Placebointragastric tap water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy normal weight subjects with a body-mass index of 19.0-24.5 or healthy obese subjects with a body-mass index of > 30
- Normal eating habits
- Age 18-40 years
- Stable body weight for at least three months
Key exclusion criteria (7 listed)
- Smoking
- Substance abuse
- Regular intake of medications (except for oral contraceptives)
- Medical or psychiatric illness
- Any abnormality detected during the screening procedure
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 |
|---|---|---|
| Placebo | Dietary supplement | Placebo |
| Glucose 25g | Dietary supplement | Glucose 25g |
| Glucose 10g | Dietary supplement | Glucose 10g |
Primary outcome
Effect of different oral glucose loads on secretion of satiation hormones
Time frame: 240min.
Plasma concentrations of glucose, insulin, glucagon, ghrelin, GLP-1, PYY and CCK are measured
1 secondary outcome
Effect of different oral glucose loads on gastric emptying
Time frame: 240min.
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 12 Jun 2013.
- Derived from this study: PubMed 26942445Meyer-Gerspach AC, Cajacob L, Riva D, Herzog R, Drewe J, Beglinger C, Wolnerhanssen BK. Mechanisms Regulating Insulin Response to Intragastric Glucose in Lean and Non-Diabetic Obese Subjects: A Randomized, Double-Blind, Parallel-Group Trial. PLoS One. 2016 Mar 4;11(3):e0150803. doi: 10.1371/journal.pone.0150803. eCollection 2016.
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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.
Christoph Beglinger, Prof principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose 25g and Glucose 10g in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 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 12 Jun 2013. 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 Switzerland. 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?
Effect of different oral glucose loads on secretion of satiation hormones (time frame: 240min.). 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 NCT01875575, 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 12 Jun 2013.