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Influence of Diabetic Neuropathy on Activation of Brown Adipose Tissue (DIA-BAT)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
cold induced activation of brown adipose tissue
Sponsored by
Doctor Giacomo Gastaldi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 1 focused on measuring diabetes, brown adipose tissue, energy expenditure, glycemic control, neuropathy, 18F-FDG PET-RMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Type 1 diabetes
  2. 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.
  3. Adult patient (>18 years old)
  4. Informed Consent form signed
  5. Differentiated inclusion:

    • Group A: absence of neuropathy
    • Group B: significant neuropathy

Exclusion Criteria:

  1. Treatment with beta-blockers
  2. Alcohol consumption(> 50 gr/week)
  3. Allergy to 18F-FDG
  4. Participation in another clinical study (4 weeks prior to entry) that may influence the activity of brown adipose tissue
  5. Pregnancy
  6. Exposure to ionizing radiation greater than or equal to 5 mSv during the year preceding the PET-RMI planned in the study

Sites / Locations

  • Geneva University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients without Neuropathy

Patients with Neuropathy

Arm Description

activation of cold induced brown adipose tissue

activation of cold induced brown adipose tissue

Outcomes

Primary Outcome Measures

brown adipose tissue activation
PET- MRI measurement (SUVR)

Secondary Outcome Measures

Energy expenditure
indirect calorimetry measurement

Full Information

First Posted
September 26, 2018
Last Updated
May 7, 2019
Sponsor
Doctor Giacomo Gastaldi
Collaborators
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT03695731
Brief Title
Influence of Diabetic Neuropathy on Activation of Brown Adipose Tissue
Acronym
DIA-BAT
Official Title
Influence of Diabetic Neuropathy on Activation of Brown Adipose Tissue
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Anticipated)
Study Completion Date
October 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Doctor Giacomo Gastaldi
Collaborators
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Influence of diabetic neuropathy on cold induced brown adipose tissue in type 1 diabetic patients.
Detailed Description
The prevalence of type 1 diabetes has been steadily increasing for about 20 years. Despite therapeutic progress, between 20 and 65% of people with diabetes develop diabetic neuropathy, resulting in increased morbidity and mortality. Diabetic neuropathy is not limited to sensitive pain in the lower limbs. It also affects the fibres of the autonomic nervous system (ANS), which results in systemic complications, often disabling (erectile dysfunction, dysidrosis, gastroparesis, orthostatism, etc.) and a probable alteration in the body's thermogenic capacities, although this possibility has not been studied in humans. In rodents, it is possible to activate induced thermogenesis via central stimulation of the ANS or to inactivate it, which promotes the development of obesity and greater insulin resistance. This knowledge is based on cellular and animal models that have identified the bio-molecular mechanisms that give brown adipose tissue (BAT) the ability to dissipate energy in the form of heat. Induced thermogenesis is mediated by decoupling proteins 1 (DCS-1) located on the mitochondrial inner membrane of the TAB. DCS-1 decouple oxidative phosphorylation from ATP production, dissipating the proton gradient. The activation of UCP1 is particularly influenced by the sympathetic system and more particularly by catecholamines which will bind to ß3 adrenergic receptors (Rß3). In humans, the persistence of active areas of TAB has recently been demonstrated by positron emission tomography (PET) imaging using a glucose analogue radiotracer, 18F-Fluoro-Deoxy-Glucose (18F-FDG), coupled with the scanner (CT). Recently, it has been shown that the use of 18F-FDG PET coupled with magnetic resonance (MRI) is equally effective in differentiating TAB from white fat tissue with less patient irradiation. The activity of the TAB is estimated using the measurement of SUV (standard uptake value) which represents the total glycolytic activity of the tissue and is also commonly referred to as the total metabolic volume. It has been shown in humans that TAB activity is inversely correlated with body mass index and age and positively correlated with exposure to cold and stress levels[6]. Among diabetics, the data are disparate but the spontaneous prevalence of TAB appears to be reduced compared to the general population (1.1% vs 7.5%). To date, no studies have investigated a possible link between the decrease in TAB activity observed in diabetics and the presence of autonomic neuropathy, which is a common and often under-diagnosed complication of diabetes. The main purpose of this study is to evaluate whether the activity and distribution of TAB in patients with diabetes is influenced by the presence of diabetic neuropathy. On the other hand, if the existence of diabetic neuropathy influences energy expenditure in the event of exposure to cold. Finally, whether any differences in the activity and distribution of TAB could be related to changes in the central nervous system. The investigators plan to include a total of 24 patients with type 1 diabetes and separate them into 2 groups: group A; no neuropathic complications and group B; presence of neuropathy. All patients will be characterized in terms of clinical, metabolic and energy expenditure. The activity of the TAB will be evaluated through the use of 18F-FDG PET/IRM imaging, after a cold stimulation protocol (refrigerated jacket) in order to activate the TAB in a homogeneous manner among the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
diabetes, brown adipose tissue, energy expenditure, glycemic control, neuropathy, 18F-FDG PET-RMI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients without Neuropathy
Arm Type
Experimental
Arm Description
activation of cold induced brown adipose tissue
Arm Title
Patients with Neuropathy
Arm Type
Experimental
Arm Description
activation of cold induced brown adipose tissue
Intervention Type
Procedure
Intervention Name(s)
cold induced activation of brown adipose tissue
Intervention Description
cold exposure wearing a cold life jacket
Primary Outcome Measure Information:
Title
brown adipose tissue activation
Description
PET- MRI measurement (SUVR)
Time Frame
120 minutes after cold exposure
Secondary Outcome Measure Information:
Title
Energy expenditure
Description
indirect calorimetry measurement
Time Frame
before and 120 minutes after cold exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Differentiated inclusion: Group A: absence of neuropathy Group B: significant neuropathy Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giacomo Gastaldi, Dr.
Phone
+41795533638
Email
giacomo.gastaldi@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Semac
Phone
+41795535617
Email
isabelle.semac@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giacomo Gastaldi, Dr.
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospital
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Gastaldi
Email
giacom.gastaldi@hcuge.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Influence of Diabetic Neuropathy on Activation of Brown Adipose Tissue

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