Influence of Diabetic Neuropathy on Activation of Brown Adipose Tissue
DIA-BAT
1 other identifier
interventional
24
1 country
1
Brief Summary
Influence of diabetic neuropathy on cold induced brown adipose tissue in type 1 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
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
First Submitted
Initial submission to the registry
September 26, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2019
CompletedMay 9, 2019
May 1, 2019
1 year
September 26, 2018
May 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
brown adipose tissue activation
PET- MRI measurement (SUVR)
120 minutes after cold exposure
Secondary Outcomes (1)
Energy expenditure
before and 120 minutes after cold exposure
Study Arms (2)
Patients without Neuropathy
EXPERIMENTALactivation of cold induced brown adipose tissue
Patients with Neuropathy
EXPERIMENTALactivation of cold induced brown adipose tissue
Interventions
cold exposure wearing a cold life jacket
Eligibility Criteria
You may qualify if:
- Type 1 diabetes
- Patients who can understand the issue of this study and who are able to decide for themselves whether or not to participate in the study.
- Adult patient (\>18 years old)
- Informed Consent form signed
- Group A: absence of neuropathy
- Group B: significant neuropathy
You may not qualify if:
- Treatment with beta-blockers
- Alcohol consumption(\> 50 gr/week)
- Allergy to 18F-FDG
- Participation in another clinical study (4 weeks prior to entry) that may influence the activity of brown adipose tissue
- Pregnancy
- Exposure to ionizing radiation greater than or equal to 5 mSv during the year preceding the PET-RMI planned in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Doctor Giacomo Gastaldilead
- University Hospital, Genevacollaborator
Study Sites (1)
Geneva University Hospital
Geneva, 1205, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giacomo Gastaldi, Dr.
University Hospital, Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
September 26, 2018
First Posted
October 4, 2018
Study Start
October 15, 2018
Primary Completion
October 15, 2019
Study Completion
October 15, 2019
Last Updated
May 9, 2019
Record last verified: 2019-05