Glucose Metabolism DisordersAlfaExNCT03241303
Delineation of the Role of Glucagon-like Peptide-1 Signalling in Relation to Increased Carbohydrate Content in the Distal Small Intestines
A study testing Acarbose and Exendin (9-39) in people with Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Acarbose and Exendin (9-39)
- 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
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2017to 1 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy
- Caucasian ethnicity
- Normal haemoglobin
- Age >18 years
- BMI >23 kg/m2 and <35 kg/m2
- Informed and written consent
Who cannot join
- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
- Treatment with medicine that cannot be paused for 12 hours
- Intake of antibiotics two months prior to study
- Treatment with glucose-lowering drugs other than metformin
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- Hypo- and hyperthyroidism
- Treatment with oral anticoagulants
- Active or recent malignant disease
- Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- Lack of effective birth control in premenopausal women
- Positive pregnancy test on study days in premenopausal women
- Pregnancy
- Women who are breastfeeding
- Any condition considered incompatible with participation by the investigators
- If the subjects receive any antibiotic treatment while included in the study they will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Glucagon-like Peptide-1 Receptor Signalling in the Glucose-lowering Effect of Increased Carbohydrate Content in the Distal Small Intestines After Meal Ingestion in Patients With Type 2 Diabetes
Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes
Read the detailed description
The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Acarbose, Placebo Oral Tablet, Exendin (9-39), Placebo Saline
- Keywords
- Glp-1, alpha-glucosidase inhibitor, acarbose
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called Glucobay, Precose
Glucobay tablets on experimental day.
Placebo Oral TabletDrug
Placebo tablets on experimental day.
Exendin (9-39)Drug
Also called Ex(9-39)
Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.
Placebo SalineDrug
9 mg/ml placebo saline infusion on experimental day.
| Study group | Role | What they receive |
|---|---|---|
| Acarbose | Experimental | 50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose Receives: Drug: Acarbose |
| Placebo Oral tablets | Placebo comparator | 180 mg. 2 weeks. Receives: Drug: Placebo Oral Tablet |
| Exendin (9-39) | Experimental | Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day. Receives: Drug: Exendin (9-39) |
| Placbo Saline | Placebo comparator | 9 mg/ml placebo saline infusion on experimental day. Receives: Drug: Placebo Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
The primary outcome is the difference between the effect of increased carbohydrate content in the distal part of the small intestine (obtained by inhibiting alpha-glucosidase with acarbose) on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin(9-39).
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Aug 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Niels Bjørn Dalsgaard, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Study director, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241303
- Sponsor's protocol ID
- H-17007893
- Acronym
- AlfaEx
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Glucagon-like Peptide-1 Receptor Signalling in the Glucose-lowering Effect of Increased Carbohydrate Content in the Distal Small Intestines After Meal Ingestion in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03241303
- Acronym / sponsor ID
- AlfaEx / H-17007893
- Conditions
- Glucose Metabolism Disorders
- Keywords
- Glp-1, alpha-glucosidase inhibitor, acarbose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 7 Aug 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.
Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes
Detailed description
The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acarbose | Experimental | Drug: Acarbose50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose |
| Placebo Oral tablets | Placebo comparator | Drug: Placebo Oral Tablet180 mg. 2 weeks. |
| Exendin (9-39) | Experimental | Drug: Exendin (9-39)Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day. |
| Placbo Saline | Placebo comparator | Drug: Placebo Saline9 mg/ml placebo saline infusion on experimental day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy
- Caucasian ethnicity
- Normal haemoglobin
- Age >18 years
- BMI >23 kg/m2 and <35 kg/m2
Key exclusion criteria (16 listed)
- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
- Treatment with medicine that cannot be paused for 12 hours
- Intake of antibiotics two months prior to study
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 |
|---|---|---|
| AcarboseAlso: Glucobay, PrecoseGlucobay tablets on experimental day. | Drug | Acarbose |
| Placebo Oral TabletPlacebo tablets on experimental day. | Drug | Placebo Oral tablets |
| Exendin (9-39)Also: Ex(9-39)Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day. | Drug | Exendin (9-39) |
| Placebo Saline9 mg/ml placebo saline infusion on experimental day. | Drug | Placbo Saline |
Primary outcome
Plasma glucose
Time frame: 240 min
The primary outcome is the difference between the effect of increased carbohydrate content in the distal part of the small intestine (obtained by inhibiting alpha-glucosidase with acarbose) on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin(9-39).
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 26 Mar 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.
Filip K Knop, MD, PhD study director
University Hospital, Gentofte, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acarbose and Exendin (9-39) in people with Glucose Metabolism Disorders, run by University Hospital, Gentofte, 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 6 inclusion and 16 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 26 Mar 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?
Plasma glucose (time frame: 240 min). 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 26 Mar 2020.