Type 2 Diabetes MellitusEGP_GlucagonNCT02010827
Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion
An observational study of Type 2 Diabetes Mellitus, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- isoglycemic intravenous glucose infusion and Glucagon infusion, day C, Oral glucose tolerance test, day A and intravenous iv glucose infusion, day B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Aug 2015
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with type 2 diabetes Healthy control subjects
Who may be able to join
- Patients with T2DM
- Caucasions above 35 years of age with diet and/or tablettreated T2DM of at -least three months (diagnosis acording to WHO)
- Normal haemoglobin
- Informed consent
- Healthy Subjects
- Normal fasting plasma glucose (FPG) and normal HbA1C (according to the -World Health Organization (WHO) criteria)
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- Normal haemoglobin
- Age above 35 years
- Informed consent
Who cannot join
- Inflammatory bowel disease
- Nephropathy (serum creatinine >150 µM and/or albuminuria)
- Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3×normal values)
- Pregnancy and/or breastfeeding
- Age above 80 years
- Any condition that the investigator feels would interfere with trial participation
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- Patients with T2DM
- Healthy Subjects
- Diabetes mellitus (DM)
- Prediabetes (impaired glucose tolerance and/or impaired FPG)
- First degree relatives with DM
- Inflammatory bowel disease
- Intestinal resection and/or ostomy
- Nephropathy (serum creatinine >150 µM and/or albuminuria
- Liver disease (ALAT and/or serum ASAT >2×normal values)
- Pregnancy and/or breastfeeding
- Age above 80 years
- Any condition that the investigator feels would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Diabetes Research Division, University Hospital Gentofte
Hellerup, 2900
About this study
We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.
Read the detailed description
Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon secretion after a meal or after ingestion of glucose. Previous studies have shown that gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been possible to determine whether this lack of glucagon suppression postprandially results in an increased endogenous glucose secretion, and thus is a factor in the patients postprandial hyperglycemia.
We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions with and without a continuous glucagon infusion in patients with T2DM and healthy control subjects. The glucagon infusion is aiming at copying the inappropriate "physiological" glucagon response observed in patients with T2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- isoglycemic intravenous glucose infusion and Glucagon infusion, day C, Oral glucose tolerance test, day A, intravenous iv glucose infusion, day B
- Keywords
- Diabetes mellitus, Glucagon, Endogenous glucose production, Incretin hormones
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isoglycemic intravenous glucose infusion and Glucagon infusion, day CBiological
Infusion of 0.8ng/kg/min glucagon from time 0-25min
Oral glucose tolerance test, day ABiological
intravenous iv glucose infusion, day BBiological
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients Receives: Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C; Biological: Oral glucose tolerance test, day A; Biological: intravenous iv glucose infusion, day B | |
| healthy controls | healthy controls Receives: Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C; Biological: Oral glucose tolerance test, day A; Biological: intravenous iv glucose infusion, day B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)
calculated based on infusions of stable isotope marked glucose
Measured: Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.
Secondary outcomes (4)
Differences in glucagon during the three days measured as total Area under the curve (tAUC)
Measured: Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.
Differences in incretin hormone levels during the three days measured as total Area under the curve (tAUC)
GIP and GLP-1
Measured: incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180, 240 min on all days.
Differences in gastrointestinal hormones during the three days measured as total Area under the curve (tAUC)
Measured: At the end of the study
differences in appetite, hunger, satiety between the three days
Will be measured with visual analogue scales (VAS)
Measured: Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180, 240 min during each day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionAug 2015
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 Type 2 Diabetes MellitusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asger Lund, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010827
- Sponsor's protocol ID
- H-4-2013-012
- Acronym
- EGP_Glucagon
- Status last verified
- Nov 2015
- First submitted
- 27 Nov 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lund A, Bagger JI, Christensen M, Grondahl M, van Hall G, Holst JJ, Vilsboll T, Knop FK. Higher Endogenous Glucose Production During OGTT vs Isoglycemic Intravenous Glucose Infusion. J Clin Endocrinol Metab. 2016 Nov;101(11):4377-4384. doi: 10.1210/jc.2016-1948. Epub 2016 Aug 17.
PubMed 27533305
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion
- ClinicalTrials.gov ID
- NCT02010827
- Acronym / sponsor ID
- EGP_Glucagon / H-4-2013-012
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes mellitus, Glucagon, Endogenous glucose production, Incretin hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Dec 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.
We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.
Detailed description
Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon secretion after a meal or after ingestion of glucose. Previous studies have shown that gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been possible to determine whether this lack of glucagon suppression postprandially results in an increased endogenous glucose secretion, and thus is a factor in the patients postprandial hyperglycemia.
We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions with and without a continuous glucagon infusion in patients with T2DM and healthy control subjects. The glucagon infusion is aiming at copying the inappropriate "physiological" glucagon response observed in patients with T2DM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C, Biological: Oral glucose tolerance test, day A, Biological: intravenous iv glucose infusion, day BPatients |
| healthy controls | – | Biological: isoglycemic intravenous glucose infusion and Glucagon infusion, day C, Biological: Oral glucose tolerance test, day A, Biological: intravenous iv glucose infusion, day Bhealthy controls |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes Healthy control subjects
Key inclusion criteria (9 listed)
- Patients with T2DM
- Caucasions above 35 years of age with diet and/or tablettreated T2DM of at -least three months (diagnosis acording to WHO)
- Normal haemoglobin
- Informed consent
- Healthy Subjects
Key exclusion criteria (18 listed)
- Inflammatory bowel disease
- Nephropathy (serum creatinine >150 µM and/or albuminuria)
- Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3×normal values)
- Pregnancy and/or breastfeeding
- Age above 80 years
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 |
|---|---|---|
| isoglycemic intravenous glucose infusion and Glucagon infusion, day CInfusion of 0.8ng/kg/min glucagon from time 0-25min | Biological | Patients, healthy controls |
| Oral glucose tolerance test, day A | Biological | Patients, healthy controls |
| intravenous iv glucose infusion, day B | Biological | Patients, healthy controls |
Primary outcome
Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)
Time frame: Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.
calculated based on infusions of stable isotope marked glucose
4 secondary outcomes
Differences in glucagon during the three days measured as total Area under the curve (tAUC)
Time frame: Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.
Differences in incretin hormone levels during the three days measured as total Area under the curve (tAUC)
Time frame: incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180, 240 min on all days.
Differences in gastrointestinal hormones during the three days measured as total Area under the curve (tAUC)
Time frame: At the end of the study
differences in appetite, hunger, satiety between the three days
Time frame: Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180, 240 min during each day.
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 2 Dec 2015.
- Derived from this study: PubMed 27533305Lund A, Bagger JI, Christensen M, Grondahl M, van Hall G, Holst JJ, Vilsboll T, Knop FK. Higher Endogenous Glucose Production During OGTT vs Isoglycemic Intravenous Glucose Infusion. J Clin Endocrinol Metab. 2016 Nov;101(11):4377-4384. doi: 10.1210/jc.2016-1948. Epub 2016 Aug 17.
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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?
An observational study of Type 2 Diabetes Mellitus, 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 9 inclusion and 18 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 2 Dec 2015. 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?
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?
Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC) (time frame: Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.). 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 NCT02010827, 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 2 Dec 2015.