- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00639613
The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia (T2DM-PC1-2)
June 25, 2015 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen
Exspression of Prohormone Convertase 1 and 2 in Small Intestinal Endocrine Mucosa Cells in Patients With Type 2 Diabetes
The purpose of this study is to determine whether excessive secretion of glucagon in type 2 diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the small intestinal.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Hyperglucagonemia contributes significantly to the hyperglycemia characterizing patients with Type 2 diabetes.
Fasting hyperglucagonemia induces hepatic glucose release resulting in elevated fasting levels of plasma glucose.
Furthermore, lack of postprandial suppression of glucagon secretion - exchanged for a paradoxical postprandial hypersecretion of glucagon - results in increased levels of postprandial plasma glucose.
Additionally, type 2 diabetes is characterized by decreased postprandial responses of the insulinotropic (and glucagonostatic) peptide hormone glucagon-like peptide-1 (GLP-1).
Recent studies from our group suggest that the intestines are involved in the diminshed suppression of glucagon following ingestion of nutrients.
Thus, suppression of glucagon during oral glucose ingestion diminishes and reverses to stimulation while suppression during intravenous administered glucose sustains along with development of glucose intolerance.
In the small intestines mucosal endocrine L-cells secrete GLP-1, which is processed from its precursor, proglucagon, by prohormone convertase 1 (PC1).
In the pancreatic alpha-cells proglucagon is processed to glucagon via prohormone convertase 2 (PC2).
We plan to examine biopsies from the mucosa of the small intestines from patients with type 2 diabetes and from healthy subjects for glucagon production.
Furthermore, the volunteers will be subjected to a standard meal test in order to correlate the gene expression studies with the level of postprandial hyperglucagonemia of the subjects.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Copenhagen County
-
Hellerup, Copenhagen County, Denmark, 2900
- Department of Internal Medicine F' laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with type 2 diabetes
Description
Inclusion Criteria:
- Diagnosed with type 2 diabetes for at least 3 months
- Normal hemoglobin
- Informed consent
Exclusion Criteria:
- Liver disease (ALAT/ASAT > 2 x normal range)
- Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuriu)
- Treatment with medication that can not be stopped for12 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
2
Healthy subjects
|
Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time.
The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon.
The procedure is usually done with the use of conscious sedation.
The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel.
Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated.
Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube.
The overtube balloon is then deployed, and the enteroscope balloon is deflated.
The process is then continued until the entire small bowel is visualized.
Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.
Liquid meal consisting of 100 g "Ny NAN" dissolved in 300 ml water (ca.
5000 kJ) to be ingested over 5 minutes.
Blood will be sampled for 4 hours following ingestion.
Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations.
|
1
Patients with type 2 diabetes
|
Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time.
The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon.
The procedure is usually done with the use of conscious sedation.
The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel.
Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated.
Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube.
The overtube balloon is then deployed, and the enteroscope balloon is deflated.
The process is then continued until the entire small bowel is visualized.
Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.
Liquid meal consisting of 100 g "Ny NAN" dissolved in 300 ml water (ca.
5000 kJ) to be ingested over 5 minutes.
Blood will be sampled for 4 hours following ingestion.
Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Filip K Knop, MD PhD, Department of Internal Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 12, 2008
First Submitted That Met QC Criteria
March 12, 2008
First Posted (Estimate)
March 20, 2008
Study Record Updates
Last Update Posted (Estimate)
June 26, 2015
Last Update Submitted That Met QC Criteria
June 25, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-B-2007-031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Double-balloon enteroscopy
-
Shanghai Changzheng HospitalUnknownSmall-Bowel DisordersChina
-
Assiut UniversityNot yet recruiting
-
Assiut UniversityNot yet recruiting
-
King Chulalongkorn Memorial HospitalCompletedOvert Obscure Gastrointestinal BleedingThailand
-
Heidelberg UniversityUnknownCholangiographyGermany
-
University Hospital, Gentofte, CopenhagenCompleted
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...UnknownSmall Intestine Cancer | Celiac DiseaseItaly
-
University of UlmHeidelberg UniversityCompleted
-
Johns Hopkins UniversityTerminatedGastrointestinal Neoplasms | Inflammatory Bowel Disease | Gastrointestinal HemorrhageUnited States
-
Air Force Military Medical University, ChinaCompleted