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Evaluation of Adults With Endocrine and Metabolic-Related Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830308
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
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Brief Summary:

Background:

There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.

Objectives:

To learn more about conditions that affect the hormone-secreting glands (endocrine glands) in adults. To train doctors to diagnose and treat people with endocrine or metabolic conditions.

Eligibility:

Adults age 18 years and older with a known or suspected endocrine disorder.

Relatives ages 18 years and older.

Doctors will review all requests and available medical records to determine final eligibility for the protocol.

Design:

Participants will have a medical history and physical exam.

Most participants will have 1 visit, and may have follow up visits if necessary. They may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:

  • Blood, urine, and saliva tests
  • Imaging tests. These may include X-ray, ultrasound, or scans.
  • Sleep study
  • Medical photographs
  • Visits with other specialists at NIH

Participants will provide blood, urine, saliva, or tissue samples. Some of these samples may be stored in the freezer for future studies.

Participants may be asked to participate in genetic testing. They will give a blood or saliva sample for this.


Condition or disease
Endocrine Diseases

Detailed Description:

This is an observational protocol designed to collect data from adult subjects with known or suspected endocrine or metabolic disorders.

OBJECTIVE: The overall purpose of endocrine evaluations under this protocol is to increase knowledge of endocrine or metabolic diseases. Adults with known or suspected endocrine or metabolic-related condition(s) may be evaluated under this protocol for:

  1. Collection of data for endocrine related conditions (case reports, case series)
  2. Collection of data for future research
  3. Collection of samples, including leftover samples from clinically indicated tests, for future research (including genomics)

METHODS: Patients will undergo a history and physical exam, anthropometrics, vital signs and endocrine laboratory studies.

Study Design
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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Evaluation of Adults With Endocrine-Related Conditions
Actual Study Start Date : July 9, 2016
Estimated Primary Completion Date : December 20, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Adults with known or suspected endocrine or metabolic dissorde
Adults with known or suspected endocrine or metabolic dissorders


Outcome Measures
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Primary Outcome Measures :
  1. Recruit a diverse population of adult subjects with a known or suspected endocrine or metabolic disorder in order to provide NIDDK investigators and trainees with hands-on experience related to the diagnosis, management, treatment, and follow-up... [ Time Frame: 12/31/2036 ]
    The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary Clinical
Criteria
  • INCLUSION CRITERIA:
  • Participants with known or suspected endocrine disorder age 18 years and older are eligible for this protocol. Protocol investigators will make the actual selection of subjects most appropriate for clinical evaluation.
  • Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.

EXCLUSION CRITERIA:

  • Anyone under the age of 18 years old
  • Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject. Subjects who are critically ill, unstable, or with severe organ failure that may affect/limit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.
Contacts and Locations
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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): NCT02830308


Contacts
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Contact: Marissa F Lightbourne, M.D. (301) 827-0033 marissa.lightbourne@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Marissa F Lightbourne, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Additional Information:

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02830308    
Other Study ID Numbers: 160125
16-DK-0125
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 8, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .De-identified results from clinical trials will be posted on cctrials.gov
Supporting Materials: Study Protocol
Time Frame: Not otherwise specified in protocol.
Access Criteria: Only investigators will have access to the data. Publications will not include subject names, nor will they contain personal identifying information. De-identified results from clinical trials will be posted on cctrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Hormones
Endocrine
Hypercortisolism
 Bone
Hypothalamic-Pituitary Dysfunction
Natural History
Additional relevant MeSH terms:
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Endocrine System Diseases