Glucose-stimulated Pancreatic Islet and Intestinal Blood Flow in Healthy Subjects and in Type 1 Diabetes

NCT02547337 | Completed

• 1 other identifier: ISLET-PET
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes is the major type of diabetes in the young. The pathophysiology still needs clarification in order to reach feasible means of preventing the disease. This study aims in defining the differences in pancreatic and intestinal blood flow between subjects with and without type 1 diabetes and validating the methodology to achieve this. Earlier animal studies have demonstrated changes in pancreatic islet blood flow using microspheres. The aim of this study is to test and validate a method for the assessment of islet perfusion in humans using molecular imaging. The investigators hypothesize that glucose-stimulated pancreatic perfusion is enhanced specifically in islets in healthy subjects and that this increase is mostly suppressed in subjects with type 1 diabetes. Positron emission tomography (PET) is a non-invasive imaging technique, which can be used to study flow and metabolism of different organs. Using radiowater (\[15O\]H2O) and PET, cellular perfusion can be measured directly and noninvasively. Recently, diffusion weighted magnetic resonance imaging (DWI) has also been applied as a complimentary method for the assessment to quantitate changes in pancreatic blood flow. In the study 10 healthy subjects and 10 subjects with type 1 diabetes will be imaged on two separate days. Pancreatic and intestinal perfusion are first measured with \[15O\]H2O and combined PET/magnetic resonance imaging before and 5 and 15 minutes after intravenous glucose infusion. On the second day, PET imaging is replaced by dynamic DWI conducted in the same time schedule and with intravenous glucose stimulation.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Pancreatic islet blood flow acquired with PET and DWI (ml ml-1 min-1)

  healthy subjects and subjects with T1DM are studied once using imaging

  within one study day

• Intestinal blood flow acquired with PET and DWI (ml ml-1 min-1)

  healthy subjects and subjects with T1DM are studied once using imaging

  within one study day

Study Arms (2)

Type 1 diabetes

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects recruited via newspaper advertisements. Subjects with Type 1 diabetes recruited at the policlinics of endocrinology and internal medicine in the district of Turku University Hospital.

You may qualify if:

• Healthy as judged by history and examination
• Age 18-30 years
• Body mass index (BMI) 18 - 27 kg/m2
• Normal 2 h oral glucose tolerance test

You may not qualify if:

• Any chronic disease
• Pregnancy
• Blood pressure \> 140/90 mmHg
• Smoking
• Presence of any ferromagnetic objects in the body
• Any other condition that could possibly create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of the study results
• Criteria for subjects with type 1 diabetes (T1D)
• T1D diagnosed at least 5 years ago
• Age 18-30 years
• BMI 18 - 30 kg/m2
• Good or moderate glycemic control with long-acting insulin analogue combined with injections of rapid-acting insulin
• Uncomplicated T1D or with minor microvascular complications
• Any other condition or disease possibly affecting circulation, as evaluated by a physician
• Pregnancy
• Blood pressure \> 140/90 mmHg

Sponsors & Collaborators

• Turku University Hospital: lead
• Academy of Finland: collaborator

Study Sites (1)

Turku PET Centre

Turku, 20520, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, faeces

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pirjo Nuutila, Prof.

  Turku PET Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prof.

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 11, 2015
• Study Start: September 10, 2015
• Primary Completion: May 1, 2021
• Study Completion: June 10, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

FI (1)