The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia
T2DM-PC1-2
Exspression of Prohormone Convertase 1 and 2 in Small Intestinal Endocrine Mucosa Cells in Patients With Type 2 Diabetes
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedJune 26, 2015
June 1, 2015
7.3 years
March 12, 2008
June 25, 2015
Conditions
Study Arms (2)
1
Patients with type 2 diabetes
2
Healthy subjects
Interventions
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.
Eligibility Criteria
Patients with type 2 diabetes
You may qualify if:
- Diagnosed with type 2 diabetes for at least 3 months
- Normal hemoglobin
- Informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal Medicine F' laboratory
Hellerup, Copenhagen County, 2900, Denmark
Biospecimen
Buffy coat
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filip K Knop, MD PhD
Department of Internal Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Diabetes Research Division
Study Record Dates
First Submitted
March 12, 2008
First Posted
March 20, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2015
Last Updated
June 26, 2015
Record last verified: 2015-06