Gastrointestinal Motility Among Diabetes Patients

NATerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

February 11, 2019

Study Completion Date

February 11, 2019

Conditions
Diabetic Autonomic NeuropathyGastrointestinal Motility DisorderDiabetes MellitusChange of Transit or Circulation
Interventions
RADIATION

11C Donepezil PET/CT scan

Donepezil binds with high affinity to acetylcholine esterase in the cholinergic synapses. The quantity of density of acetylcholine esterase in the abdominal organs including the intestinal wall are demonstrated by 11C Donepezil PET/CT scan. The PET-signal are measured as Standard-uptake values (SUV) in the internal organs. After 6 hours of fast CT- and PET-scans are performed after injection of iv. contrast and about 500MBq (megabecquerel) \[11C\]donepezil. The CT scan is used for anatomical location of the internal organs. The scan-field includes the heart and the abdominal organs. Total scan time is about 60 minutes.

DEVICE

3D-Transit

"3D-Transit: 3D-Transit for minimal invasive and ambulant describing of regional transit times and contractions pattern of the bowel. The motility and the passage time is measured by 3D-Transit The description of location and rotation of the capsule is dynamic and very precise. It permits precise detailed description of the gastrointestinal contraction pattern and regional passage time. 3D-transit consist of three different parts:~1. A wireless electromagnetic capsule to be swallowed by the subject~2. A portable detector plate comprising four sensors worn in a belt around the waist~3. Specific software for visualizing and analyzing data"

DRUG

3D-Transit during treatment with Pyridostigmine

3D-Transit and Pyridostigmine: The motility and the passage time is measured by 3D-Transit (as mentioned above) in diabetic patients during administration of Pyridostigmine 60 mg administrated 4 times with 4 hours between each administration. Pyridostigmine is increasing the amount of cholinergic neurotransmitter and is suggested to have a reversible effect on the cholinergic denervation. The mechanism of action of Pyridostigmine in the human body is well-known and the drug is used as a tool to determine if the disturbance in the guts are reversible in diabetic patients.

DEVICE

3D-Transit after Malone appendicostomy

3D-Transit (as earlier described) is performed after Malone appendicostomy. The patients are suppose use the antegrade edema technic during the 3D-transit examination.

Trial Locations (1)

8000

Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

collaborator

Svend Faelding Humanitarian Foundation

UNKNOWN

collaborator

Copenhagen University Foundation for Medical Students

UNKNOWN

collaborator

Hoejmosegaard Foundation

UNKNOWN

collaborator

Holger Rabitz og Hustru Doris Mary foedt Phillipps Mindelegat

UNKNOWN

collaborator

Lundbeck Foundation

OTHER

collaborator

Wilhelm Frank og Angelina Franks Mindelegat

UNKNOWN

collaborator

Torben og Alice Frimodts Fond

UNKNOWN

collaborator

Fonden til Lægevidenskabens Fremme, A.P. Møller Fonden

UNKNOWN

lead

University of Aarhus

OTHER

NCT02573519 - Gastrointestinal Motility Among Diabetes Patients | Biotech Hunter | Biotech Hunter