NCT04694547

Completed

Ketogenic Diet Survey in Patients With McArdle Disease (GSDV...

Nicoline Løkken Source

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Other study identifiers

Sponsor study identifier

Ketogenic diet survey in GSDV

Study Type

observational

Actual enrollment (reported)

200

Locations

1 country

Sites

1

Timeline

Study Start

January 10, 2021

Actual (reported)

Primary Completion

November 1, 2022

Actual (reported)

Study Completion

December 1, 2022

Actual (reported)

Brief Summary

The purpose of this survey is to report experiences with variants of a ketogenic diet in a group of individuals diagnosed with McArdle disease (glycogen storage disease type V). Further more the survey will report on physical activity, fatigue, sleep and quality of life in this cohort.

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): 200 participants
Study completion date: December 1, 2022
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
October 5, 2020
Actual (reported)
First Posted
January 5, 2021
Actual (reported)
Study Start
January 10, 2021
Actual (reported)
Primary Completion
November 1, 2022
Actual (reported)
Study Completion
December 1, 2022
Actual (reported)

Last Updated: February 13, 2023
Status Verified: February 2023
Last Update Submitted: February 10, 2023

Conditions

McArdle Disease

Outcome Measures

Primary Outcomes (5)

Questions on experiences with a ketogenic diet
Survey
Baseline
IPAQ (INTERNATIONAL PHYSICAL ACTIVITY QUESTIONNAIRE) short form
Survey
Baseline
MFI-20 (MULTIDIMENSIONAL FATIGUE INVENTORY)
Survey
Baseline
ISI (insomnia severity index)
Survey
Baseline
MGQOL 15 score (Myasthenia Gravis Quality Of Life)
Survey
Baseline

Interventions

There is no intervention, as this is a survey studyOther

Survey

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

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

McArdle disease

You may qualify if:

Verified GSDV diagnosis

You may not qualify if:

Sponsors & Collaborators

Nicoline Løkken
Otherlead

Study Sites (1)

Copenhagen Neuromuscular Center, Rigshospitalet

Copenhagen, Denmark

Related Publications (1)

Reason SL, Lokken N, Voermans N. International patient group harnesses social media to help inform rare disease research: use of a low carbohydrate ketogenic diet in McArdle disease. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):441-445. doi: 10.1097/MED.0000000000000663.
PMID: 34269712DERIVED

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

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator, MD

Study Record Dates

First Submitted

October 5, 2020

First Posted

January 5, 2021

Study Start

January 10, 2021

Actual (reported)

NCT04226274

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

Phase 1Completed

NCT02432768

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

Phase 2Completed

NCT03112889

Sodium Valproate for GSDV

Phase 2Completed

NCT02919631

Triheptanoin in Mc Ardle

Phase 2Completed

NCT04349566

Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases

Completed

NCT04929002

Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases

Active Not Recruiting

Age under 18 years

Contact the study team to confirm eligibility.

Primary Completion

November 1, 2022

Actual (reported)

Study Completion

December 1, 2022

Actual (reported)

Last Updated

February 13, 2023

Record last verified: 2023-02

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: NCT04694547
Data provider: ClinicalTrials.gov
Source updated: 2023-02-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:46 UTC

Locations

DK(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations