NCT03843606

Completed

Modified Ketogenic Diet in Patients With McArdle Disease Par...

Copenhagen University Hospital, Rigshospitalet Source

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Other study identifiers

Sponsor study identifier

H-18013022

Study Type

interventional

Actual enrollment (reported)

11

Locations

1 country

Sites

1

Timeline

Study Start

February 16, 2019

Actual (reported)

Primary Completion

May 1, 2019

Actual (reported)

Study Completion

May 8, 2019

Actual (reported)

Brief Summary

McArdle disease, glycogen storage disease type V, is a rare metabolic disease. Affected individuals are unable to utilize sugar stored as glycogen in muscle. We hypothesize that a modified ketogenic diet could be a potential treatment option, by providing ketones as alternative fuel substrates for working muscle. In this open interventional pilot study we wish to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet that ensures adequate degree of ketosis and at the same time is well tolerated for patients with McArdle disease.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 11 participants
Study completion date: May 8, 2019
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 12, 2018
Actual (reported)
Study Start
February 16, 2019
Actual (reported)
First Posted
February 18, 2019
Actual (reported)
Primary Completion
May 1, 2019
Actual (reported)
Study Completion
May 8, 2019
Actual (reported)

Last Updated: May 10, 2019
Status Verified: May 2019
Last Update Submitted: May 9, 2019

Conditions

McArdle Disease

Outcome Measures

Primary Outcomes (1)

Heart rate
heart rate during constant load cycling exercise
2 times

Secondary Outcomes (6)

Compliance
3 weeks
indirect calorimetry
2 times
level of ketosis
daily
Safety parameters
2 times
Perceived exertion
2 times
+1 more secondary outcomes

Study Arms (3)

diet 1

EXPERIMENTAL

60% fat, 15% protein, 25% carbohydrates

Other: Modified ketogenic diets

diet 2

EXPERIMENTAL

70% fat, 15% protein, 15% carbohydrates

Other: Modified ketogenic diets

diet 3

EXPERIMENTAL

80% fat, 15% protein, 5% carbohydrates

Other: Modified ketogenic diets

Interventions

Modified ketogenic dietsOther

Different diet composition

diet 1diet 2diet 3

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Genetically confirmed GSDV
Patient is willing and able to provide written informed consent prior to participation.

Sponsors & Collaborators

Copenhagen University Hospital, Rigshospitalet
Otherlead

Study Sites (1)

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, Denmark

MeSH Terms

Conditions

Glycogen Storage Disease Type V

Condition Hierarchy (Ancestors)

Glycogen Storage DiseaseCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Enrollment

11 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PhD-student

Study Record Dates

First Submitted

December 12, 2018

First Posted

February 18, 2019

Study Start

February 16, 2019

Actual (reported)

NCT02432768

The Effect of Triheptanoin in Adults With McArdle Disease (Glycogen Storage Disease Type V)

Phase 2Completed

NCT04226274

A Study of the Safety of REN001 in Patients With McArdle Disease

Phase 1Completed

NCT03112889

Sodium Valproate for GSDV

Phase 2Completed

NCT02919631

Triheptanoin in Mc Ardle

Phase 2Completed

NCT02635269

Fat and Sugar Metabolism During Exercise in Patients With Metabolic Myopathy

Not ApplicableUnknown

NCT04929002

Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases

Active Not Recruiting

Patient is ambulatory.

Women in fertile age must be willing to practice the following medically acceptable methods of birth control

You may not qualify if:

Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
Pregnancy or breastfeeding
Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments
Patients with porphyria or disorders of fat metabolism (primary carnitine deficiency, carnitine palmitoyltransferase I or II, β-oxidation defects etc.).

Contact the study team to confirm eligibility.

Primary Completion

May 1, 2019

Actual (reported)

Study Completion

May 8, 2019

Actual (reported)

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03843606
Data provider: ClinicalTrials.gov
Source updated: 2019-05-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:29 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (3)

diet 1

diet 2

diet 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations