Clinical trial NCT01826422: Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients
Official title: Effect of Eicosapentaenoic Fatty Acid (EPA) and Docosahexaenoic Fatty Acids (DHA) Supplementation on the Inflammation State and Metabolic Disorders in Patients With Duchenne Muscular Dystrophy or Becker Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophy, Duchenne
Keywords: Muscular Dystrophy
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Omega 3
Eicosapentaenoic fatty acid
Docosahexaenoic fatty acid
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Rehabilitacion
First posted: 2013-04-08
Enrollment: 40
Sex: MALE
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well as the process of muscular regeneration and the metabolic disorders like obesity and insulin resistance in patients with Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (DMB) compared to those receiving placebo.

Detailed description: DMD and DMB are X-linked diseases caused by mutations in the DMD gene, these mutations have important functional and structural consequences in skeletal muscle. In muscle fiber is observed inflammation and necrosis as a result of lost regenerative capacity. The muscle fibers can be replaced by connective and adipose tissue. In a previous study the investigators identified that 50% of Duchenne and Becker patients in the range of thirteen years old have obesity. In addition, these patients (N=66) have hyperinsulinemia (53.7%) and insulin resistance (48.5%). It is well known that obesity, hyperinsulinemia and insulin resistance have a inflammatory background.

It has been demonstrated that eicosapentaenoic fatty acid (EPA) and docosahexaenoic fatty acid (DHA) exhibit anti-inflammatory properties and have beneficial effects on obesity, hyperinsulinemia and insulin resistance in children and adolescents.

Objective: Determine the effect of EPA and DHA on inflammation, obesity and insulin resistance in patients with DMD/DMB compared to those receiving placebo.

Eligibility criteria: Inclusion Criteria:

* Written informed consent and assent by the patient and both parents or guardian.
* Patients with clinical diagnosis of Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (DMB)
* Patients were not under treatment with corticosteroids

Exclusion Criteria:

* Patients decided to withdraw from the study
* Consumption of dietary supplements containing polyunsaturated fatty acids omega 3.
* With hypersensitivity to fish oil.
* Patients with respiratory and gastrointestinal problems. Medical responsible assessment the presence of respiratory and gastrointestinal problems.
* Patients with difficulty swallowing food, including those who have the difficulty ingesting oil capsules.
* Gastrostomy fed patients.

Primary outcomes:
measure: Body Composition (Body Fat)
timeFrame: At baseline and at months 3 and 6 of supplementation.
measure: Lean Mass
timeFrame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
measure: Anthropometric Measurement: Body Mass Index
timeFrame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
measure: Glucose in Serum
timeFrame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
measure: Insulin in Blood
timeFrame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Secondary outcomes:
measure: Inflammation Biomarkers (TNF-A)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Inflammation Biomarkers (IL-1)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Inflammation Biomarkers (IL-6)
timeFrame: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.
measure: Inflammation Biomarkers (IL-10)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Inflammation Biomarker (IL-6 Expression)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Inflammation Biomarker (TNF-A Expression)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Inflammation Biomarker (IL-1 Expression)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Markers of Muscle Degeneration (Creatinine Kinase)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Markers of Muscle Degeneration (MMP9)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 of supplementation.
measure: Markers of Muscle Degeneration (sFas)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Markers of Muscle Degeneration (Receptor of Fas)
timeFrame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Markers of Muscle Regeneration (VEGF)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Markers of Muscle Regeneration (FGF)
timeFrame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
measure: Incorporation of DHA in the Erythrocytes
timeFrame: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
measure: Incorporation of EPA in the Erythrocytes
timeFrame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS.
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Maricela Rodriguez-Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cruz Guzman Odel R, Chavez Garcia AL, Rodriguez-Cruz M. Muscular dystrophies at different ages: metabolic and endocrine alterations. Int J Endocrinol. 2012;2012:485376. doi: 10.1155/2012/485376. Epub 2012 Jun 3.
citation: Rodriguez-Cruz M, Sanchez R, Escobar RE, Cruz-Guzman Odel R, Lopez-Alarcon M, Bernabe Garcia M, Coral-Vazquez R, Matute G, Velazquez Wong AC. Evidence of Insulin Resistance and Other Metabolic Alterations in Boys with Duchenne or Becker Muscular Dystrophy. Int J Endocrinol. 2015;2015:867273. doi: 10.1155/2015/867273. Epub 2015 May 19.
citation: Rodriguez-Cruz M, Cruz-Guzman ODR, Almeida-Becerril T, Solis-Serna AD, Atilano-Miguel S, Sanchez-Gonzalez JR, Barbosa-Cortes L, Ruiz-Cruz ED, Huicochea JC, Cardenas-Conejo A, Escobar-Cedillo RE, Yam-Ontiveros CA, Ricardez-Marcial EF. Potential therapeutic impact of omega-3 long chain-polyunsaturated fatty acids on inflammation markers in Duchenne muscular dystrophy: A double-blind, controlled randomized trial. Clin Nutr. 2018 Dec;37(6 Pt A):1840-1851. doi: 10.1016/j.clnu.2017.09.011. Epub 2017 Sep 23.
citation: Villaldama-Soriano MA, Rodriguez-Cruz M, Hernandez-De la Cruz SY, Almeida-Becerril T, Cardenas-Conejo A, Wong-Baeza C. Pro-inflammatory monocytes are increased in Duchenne muscular dystrophy and suppressed with omega-3 fatty acids: A double-blind, randomized, placebo-controlled pilot study. Eur J Neurol. 2022 Mar;29(3):855-864. doi: 10.1111/ene.15184. Epub 2021 Nov 26.
citation: Rodriguez-Cruz M, Atilano-Miguel S, Barbosa-Cortes L, Bernabe-Garcia M, Almeida-Becerril T, Cardenas-Conejo A, Del Rocio Cruz-Guzman O, Maldonado-Hernandez J. Evidence of muscle loss delay and improvement of hyperinsulinemia and insulin resistance in Duchenne muscular dystrophy supplemented with omega-3 fatty acids: A randomized study. Clin Nutr. 2019 Oct;38(5):2087-2097. doi: 10.1016/j.clnu.2018.10.017. Epub 2018 Oct 30.