Brown Adipose Tissue in ALS

NCT03150290 | Completed

• 2 other identifiers: C16-832016-A01790-51
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Weight loss is a common phenomenon in ALS. During the course of the disease, difficulty in swallowing and mastication can be responsible for a decrease in caloric intake and thus for weight loss. However, significant weight loss can also be observed in patients with no feeding difficulties. About half of ALS patients have an increase in their resting energy consumption, but the origin of this "hypermetabolism" remains unknown. "Brown" fat is specialized in the production of heat. Unlike "white" fat that stores excess caloric intakes, brown fat consumes energy. In humans, brown fat has long been considered as absent in adults. However, recent imaging techniques have been able to detect brown fat deposits in some adult subjects. The aim of this study is thus to determine the role of brown fat on energy consumption in Amyotrophic Lateral Sclerosis.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Quantification of depots of functional brown adipose tissue in ALS patients (grams)

  measured by 18F-FDG-PET

  performed at the first visit (1 day)

Study Arms (2)

ALS patients without weight loss.

OTHER

18-FDG-PET. Indirect Calorimetry.

Other: Indirect Calorimetry.; Device: 18-FDG-PET

ALS patients with weight loss.

OTHER

18-FDG-PET. Indirect Calorimetry.

Other: Indirect Calorimetry.; Device: 18-FDG-PET

Interventions

Indirect Calorimetry. OTHER

REE measurement

ALS patients with weight loss.; ALS patients without weight loss.

18-FDG-PET DEVICE

18-FDG-PET

ALS patients with weight loss.; ALS patients without weight loss.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 85 (inclusive)
• Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
• With unexplained significant loss of weight of 5 percent (or more) of normal body weight in the last 6 months (n=5 subjects) Or - without weight loss (n= 5 subjects)

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Paris Als Center, Salpetriere Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Calorimetry, Indirect

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calorimetry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: May 12, 2017
• Study Start: October 26, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)