Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients | DuchenneXchange

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Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients

key information

study id #: NCT01826422

condition: Muscular Dystrophy, Duchenne

status: completed

purpose:

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.

intervention: EPA and DHA, Placebo Comparator

mechanism of action: Omega-3 fatty acides to reduce inflammation

results: https://clinicaltrials.gov/ct2/show/results/NCT01826422

last updated: November 22, 2018

study details

start date: March 2013

estimated completion: January 2017

phase of development: N/A

size / enrollment: 40

study 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.

primary outcomes:

  • Body Composition (Body Fat) [ Time Frame: At baseline and at months 3 and 6 of supplementation. ]
    We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).
  • Lean Mass [ Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. ]
    We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).
  • Anthropometric Measurement: Body Mass Index [ Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. ]
    We measured weight, height by anthropometric to calculate the body mass index (body mass index).
  • Glucose in Serum [ Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. ]
    A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.
  • Insulin in Blood [ Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. ]
    A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).

secondary outcomes:

  • Inflammation Biomarkers (IL-10) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
  • Inflammation Biomarker (IL-6 Expression) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).
  • Inflammation Biomarker (TNF-A Expression) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)
  • Inflammation Biomarker (IL-1 Expression) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).
  • Markers of Muscle Degeneration (Creatinine Kinase) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.
  • Markers of Muscle Degeneration (MMP9) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 of supplementation. ]
    Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.
  • Markers of Muscle Degeneration (sFas) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
  • Markers of Muscle Degeneration (Receptor of Fas) [ Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
  • Markers of Muscle Regeneration (VEGF) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).
  • Markers of Muscle Regeneration (FGF) [ Time Frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation. ]
    Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
  • Incorporation of DHA in the Erythrocytes [ Time Frame: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation. ]
    The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.
  • Incorporation of EPA in the Erythrocytes [ Time Frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6 ]
    The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.

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.

study contacts

sponsor: Coordinación de Investigación en Salud, Mexico

investigators: Maricela Rodriguez-Cruz, PhD

locations: Mexico