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Protocol Details

Clinical and Basic Investigations into Known and Suspected Congenital Disorders of Glycosylation and Deglycosylation

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-HG-0071

Sponsoring Institute

National Human Genome Research Institute (NHGRI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 mo
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Thrombosis;
Intellectual Disability;
Hypotonia;
Hypoglycemia;
Hypothyroidism;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Congenital Disorders of Glycosylation

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Human Genome Research Institute

Background:

- Proteins, fats, and other molecules are the body s building blocks. Many of these molecules must have sugars, or chains of sugars, attached to work properly. People with congenital disorders of glycosylation (CDGs) cannot attach these sugars or sugar chains properly. A child or adult with a CDG can have symptoms in different parts of the body, including brain, nerves, muscles, liver, and immune system. Researchers want to learn more about these diseases to understand better what is causing the problems.

Objective:

- To learn more about CDGs.

Eligibility:

- People 1 month to 2 years old may be seen as outpatients or by telehealth. Patients 2-80 years with CDG or suspected to have a CDG may be seen under this protocol as inpatients, outpatients or by teleheath.

Design:

-CDG participants may be seen as inpatients, outpatients or by teleheath. Inpatient stays may last 2-5 days.

-They will have:-Medical history and physical exam. They will answer questions about their CDG.

-Blood taken several times. Their skin will be numbed, then a needle will take blood from an arm vein.

-Samples taken of their skin, urine, and maybe stool and spinal fluid.

-Photos taken of their whole body. They can wear underwear and cover their eyes.

-Brain MRI. They will lie on a table that slides in and out of a metal cylinder. The scanner makes loud knocking noises so they can wear earplugs.

-Abdomen ultrasound. Sound waves take images of the body from the outside.

-Hand/wrist X-rays for young patients. They may have a full-body X-ray.

-DEXA bone density scan. Participants will lie on a table under a scanner.

-Echocardiogram and electrocardiogram for heart activity. Pads are stuck on the skin and the electrical activity of the heart is recorded.

-Tests of hearing, thinking, motor skills, and speech.

- Children participants may have tests done under sedation if it will benefit them directly.

- CDG participants may have other procedures during their visit. They may have follow-up visits every year.

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Eligibility

INCLUSION CRITERIA:

Participants 1 month or older will have been or will be referred to this protocol with a known or suspected CDG. Participants over two years of age will be admitted only if they are medically stable and require admission to the Clinical Center for diagnosis. One or more probands may be admitted to the NIH Clinical Center for investigation as well as carrier family members.

Some participants will be relatives of patients with known CDG s, and their specimens will be obtained for the purpose of heterozygote testing and to serve as controls to help diagnose the proband. Participants may be seen as inpatients, outpatients or via Telehealth. In some cases, biologic samples may be obtained remotely and sent to the Gahl lab.

EXCLUSION CRITERIA:

-Participants under 1 month of age will not be seen at the NIH Clinical center because care is more readily proffered to older individuals at the Clinical Center.

-Participants over two years of age will not be admitted if they are medically unstable and do not require admission to the Clinical Center for diagnosis.

-Pregnant women and newborns are excluded.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lynne A. Wolfe, C.R.N.P.
National Human Genome Research Institute (NHGRI)
NIHBC 10 - CRC BG RM 3-5441
10 CENTER DR
BETHESDA MD 20892
(301) 443-8577
lynne.wolfe@nih.gov

Lynne A. Wolfe, C.R.N.P.
National Human Genome Research Institute (NHGRI)
NIHBC 10 - CRC BG RM 3-5441
10 CENTER DR
BETHESDA MD 20892
(301) 443-8577
lynne.wolfe@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02089789

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