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Spinal Muscular AtrophyNCT03970135

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

A study testing Fasting in people with Spinal Muscular Atrophy and Merosin Deficient Congenital Muscular Dystrophy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 80 yearsHealthy volunteers can take part
What is being tested?
Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteDenmark
Study dates
29 May 2017to 30 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Patients with low skeletal muscle mass

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Copenhagen Neuromuscular Center

    Copenhagen, 2200

Other trials in Denmark

About this study

Official title: Fedt og Sukkerstofskiftet Under Faste Hos Patienter Med Lav Muskelmasse.

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.

Read the detailed description

Design. This is a prospective case-control study investigating fat and glucose metabolism in patients with low muscle mass during prolonged fasting, comparing results to those found in healthy controls.

Setting. All children were admitted to the Department of Pediatrics and Adolescents medicine, Rigshospitalet, and all adult subjects were admitted to the Department of Neurology, Rigshospitalet at 4 pm for a 24-hour fasting period.

Protocol. The protocol consisted of two visits. A pre-experimental visit and a study visit.

Pre-experimental visit. Total muscle mass presented as lean body mass (LBM) was measured by DEXA scan. Furthermore, pre-experimental preparations included that all subjects were instructed to follow national nutritional recommendations with a healthy diet consisting of less than 30% fat, low fat protein, long chain carbohydrates and minimize sugar intake three days before the study.

Study visit. Patients were admitted to the hospital at 16:00 hours for IV catheter placement and a standardized evening meal at 17:00. Two venous catheters were inserted, one in the cubital vein (for stable-isotope infusion) and one in the distal cephalic vein (for blood sampling). A heating pad, covering the hand and distal forearm, ensured shunting of arterial blood to the veins in order to obtain arterialized blood. A primed, constant rate infusion of [U-13C]-palmitate (0.0026 mg kg-1 min-1, primed by a 0.085 mg kg-1 NaH13CO3 bolus) and [D2]-glucose (0.0728 mg kg-1 min-1, primed by a 3.203 mg kg-1 D2- glucose bolus) was delivered by a Gemini PC2 pump (IMED, San Diego, CA). Preparation of tracers and tracer calculations were performed as described.

Blood and air samples were collected just before start of infusion of the stable isotopes, and again after 2, 10, 14, 16, 18, 20, 22 and 24 hours of fasting (figure 1). Gas exchange measurements (indirect calorimetry) were performed with a metabolic cart (Cosmed Quark b2; Cosmed Srl., Milan, Italy). At the same time-points, expired air was collected in a 15 L Douglas bag (Hans Rudolph, Kansas City, MO, USA) and 10 mL samples were transferred to vacuum tubes (Vacutainer, BD, Franklin Lakes, NJ, USA) for 13CO2 analysis.

The blood glucose levels were monitored continuously at all blood sampling times and every third hour during the night in the patients. If the subjects developed symptoms of hypoglycaemia (fatigue, dizziness, nausea) the blood sugar was measured immediately. The fasting period lasted 24 hours or until signs of hypoglycemia as mentioned above or blood glucose below 3.0 mmol/L. Patients received an IV bolus of 10% glucose according to weight if signs of hypoglycemia occurred.

Analyses of blood samples and expired 13CO2. Venous blood was transferred to cooled tubes with EDTA (Ethylenediaminetetraacetic acid) (0.33M, 10μL mL-1) and spun at 4,000 rpm for 10 minutes. Plasma was distributed to Eppendorf tubes and immediately frozen on dry ice and stored at -80°C until analysis. Plasma insulin and glucagon analyses were performed at the Department of Clinical Biochemistry at Rigshospitalet, Copenhagen, Denmark (Cobas 8000, Roche, Rotkreuz Switzerland). Plasma free fatty acids and catecholamines were analyzed by spectrophotometry (Multiskan GO, Thermo Scientific, SkanIt™ Software, Thermo Fisher Scientific Inc., USA). Plasma palmitate, β-hydroxybuturate, acetoacetate, pyruvate, glycerol and amino acids as well as 13CO2-breath enrichment were analyzed by gas chromatography isotope ratio-mass spectrometry (Thermo Finnigan MAT GmbH, Bremen, Germany). Isotope tracer enrichments were determined using gas chromatography-mass spectrometry (Thermo Finnigan MAT GmbH, Bremen, Germany).

Glucose and lactate were analyzed on (ABL 700) immediately as the blood was drawn.

Shofield equation was used to calculate expected basal metabolic rate for the children: Males 10-17 years: (17.7 x weight+657+105) and females 10-17 years: (13,4 x weight+692+112) and the results were compared with the resting metabolic rate (RMR) measured by indirect calorimetric, as described above, at the end of the study, were patients had been resting and fasting for more than 8 hours.

Being tested
Fasting
Medical subject headings
Muscular Atrophy, Spinal, Muscular dystrophy congenital, merosin negative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FastingOther

    Fasting for 24 hours or until hypoglycemia (blood glucose < 3mmol/L) or symptoms of hypoglycemia

Study groups in NCT03970135
Study groupRoleWhat they receive
FastingExperimentalNot described
Receives: Other: Fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fat metabolisms from fed to fasted state

    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

    Measured: 24 hours

  2. Change in carbohydrates metabolisms from fed to fasted state

    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

    Measured: 24 hours

Secondary outcomes (11)
  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.

    Hormones and metabolites were measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  2. Change in glucagon from fed to fasted state.

    Glucagon was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  3. Change in epinephrine from fed to fasted state.

    Epinephrine was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  4. Change in norepinephrine from fed to fasted state.

    Norepinephrine was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  5. Change in palmitate from fed to fasted state.

    Palmitate was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  6. Change in free fatty acids (FFA) from fed to fasted state.

    FFA was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  7. Change in glycerol from fed to fasted state.

    Glycerol was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  8. Change in glucose from fed to fasted state.

    Glucose was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  9. Change in pyruvate from fed to fasted state.

    Pyruvate was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  10. Change in β-hydroxybuturate from fed to fasted state.

    β-hydroxybuturatewas measured at fed state and during 24 hours of fasting

    Measured: 24 hours

  11. Change in acetoacetate from fed to fasted state.

    Acetoacetate was measured at fed state and during 24 hours of fasting

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start29 May 2017
  3. Primary completion30 Nov 2017
  4. Study completion30 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03970135
Sponsor's protocol ID
H-16049377
Status last verified
May 2019
First submitted
21 May 2019
Last updated
31 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fasting in people with Spinal Muscular Atrophy and Merosin Deficient Congenital Muscular Dystrophy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fat metabolisms from fed to fasted state (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.

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