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Fat and Glucose Metabolism in Fed and Fasted State in Patients With Low Skeletal Muscle Mass

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ClinicalTrials.gov Identifier: NCT03970135
Recruitment Status : Completed
First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Mette Cathrine Oerngreen, Rigshospitalet, Denmark

Brief Summary:
In a study from 2003 the investigators showed that adult patients with very low skeletal muscle mass (spinal muscular atrophy (SMA) type II, Duchenne muscular dystrophy, congenital muscular dystrophy) are prone to develop hypoglycemia during prolonged fasting. Since then case reports have described the same phenomenon with hypoglycemia and metabolic crises in children with low skeletal muscle mass provoked by infection, fasting and surgery. Pathophysiological mechanisms of metabolism have never been investigated in adults or children with SMA II. Thus the investigators studied fat and glucose metabolism during prolonged fasting in patients with SMA II and LAMA 2 and compared results to those found in healthy controls.

Condition or disease Intervention/treatment Phase
Spinal Muscular Atrophy Merosin Deficient Congenital Muscular Dystrophy Other: Fasting Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Fedt og Sukkerstofskiftet Under Faste Hos Patienter Med Lav Muskelmasse.
Actual Study Start Date : May 29, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017


Arm Intervention/treatment
Experimental: Fasting Other: Fasting
Fasting for 24 hours or until hypoglycemia (blood glucose < 3mmol/L) or symptoms of hypoglycemia




Primary Outcome Measures :
  1. Change in fat metabolisms from fed to fasted state [ Time Frame: 24 hours ]
    Using indirect calorimetri and stable isotope technique: of [U-13C]-palmitate (0.0026 mg kg-1 min-1, primed by a 0.085 mg kg-1 NaH13CO3 bolus) fat metabolism was measured at fed state and during 24 hours of fasting

  2. Change in carbohydrates metabolisms from fed to fasted state [ Time Frame: 24 hours ]
    Using indirect calorimetri and stable isotope technique: of [D2]-glucose (0.0728 mg kg-1 min-1, primed by a 3.203 mg kg-1 D2- glucose bolus) glucose metabolism was measured at fed state and during 24 hours of fasting


Secondary Outcome Measures :
  1. Change in insulin, glucagon, epinephrine and norepinephrine and the metabolites palmitate, free fatty acids (FFA), glycerol, glucose, pyruvate, β-hydroxybuturate, acetoacetate from fed to fasted state. [ Time Frame: 24 hours ]
    Hormones and metabolites were measured at fed state and during 24 hours of fasting

  2. Change in glucagon from fed to fasted state. [ Time Frame: 24 hours ]
    Glucagon was measured at fed state and during 24 hours of fasting

  3. Change in epinephrine from fed to fasted state. [ Time Frame: 24 hours ]
    Epinephrine was measured at fed state and during 24 hours of fasting

  4. Change in norepinephrine from fed to fasted state. [ Time Frame: 24 hours ]
    Norepinephrine was measured at fed state and during 24 hours of fasting

  5. Change in palmitate from fed to fasted state. [ Time Frame: 24 hours ]
    Palmitate was measured at fed state and during 24 hours of fasting

  6. Change in free fatty acids (FFA) from fed to fasted state. [ Time Frame: 24 hours ]
    FFA was measured at fed state and during 24 hours of fasting

  7. Change in glycerol from fed to fasted state. [ Time Frame: 24 hours ]
    Glycerol was measured at fed state and during 24 hours of fasting

  8. Change in glucose from fed to fasted state. [ Time Frame: 24 hours ]
    Glucose was measured at fed state and during 24 hours of fasting

  9. Change in pyruvate from fed to fasted state. [ Time Frame: 24 hours ]
    Pyruvate was measured at fed state and during 24 hours of fasting

  10. Change in β-hydroxybuturate from fed to fasted state. [ Time Frame: 24 hours ]
    β-hydroxybuturatewas measured at fed state and during 24 hours of fasting

  11. Change in acetoacetate from fed to fasted state. [ Time Frame: 24 hours ]
    Acetoacetate was measured at fed state and during 24 hours of fasting



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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with low skeletal muscle mass

Exclusion Criteria:

  • Competing disorders interfering with interpretation of results
  • Medication that will interfere with results
  • Compliance problems
  • Participation in other clinical trials that will interfere with interpretation of results
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970135


Locations
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Denmark
Copenhagen Neuromuscular Center
Copenhagen, Denmark, 2200
Sponsors and Collaborators
Rigshospitalet, Denmark

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Responsible Party: Mette Cathrine Oerngreen, PI, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03970135     History of Changes
Other Study ID Numbers: H-16049377
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Atrophy
Muscular Atrophy, Spinal
Atrophy
Pathological Conditions, Anatomical
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases