Evaluation of Adults With Endocrine and Metabolic-Related... | NCT02830308

Studies
Evaluation of Adults With Endocrine and Metabolic-Related Conditions

NCT02830308

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

1,250Estimated

Phase

Not provided

Conditions

Endocrine Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
16-DK-0125

Status Module

Record Verification Date

Jul 7, 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2016Actual

Primary Completion Date

Dec 20, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jul 9, 2016

First Submission Date that Met QC Criteria

Jul 11, 2016

First Posted Date

Jul 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2026

Last Update Posted Date

Jul 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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:

Collection of data for endocrine related conditions (case reports, case series)
Collection of data for future research
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults with known or suspected endocrine or metabolic dissorde		Adults with known or suspected endocrine or metabolic dissorders

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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...	The overall purpose of endocrine evaluations under this protocol is to support our clinical training and research missions.	12/31/2036

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Primary Clinical

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marissa F Lightbourne, M.D.	Contact	(301) 827-0033		marissa.lightbourne@nih.gov

Overall Officials

Name	Affiliation	Role
Marissa F Lightbourne, M.D.	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center	Recruiting	Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39069898	Derived	Abd-Elmoniem KZ, Edwan JH, Dietsche KB, Villalobos-Perez A, Shams N, Matta J, Baumgarten L, Qaddumi WN, Dixon SA, Chowdhury A, Stagliano M, Mabundo L, Wentzel A, Hadigan C, Gharib AM, Chung ST. Endothelial Dysfunction in Youth-Onset Type 2 Diabetes: A Clinical Translational Study. Circ Res. 2024 Aug 30;135(6):639-650. doi: 10.1161/CIRCRESAHA.124.324272. Epub 2024 Jul 29.

ID	Term
D004700	Endocrine System Diseases
D003480	Cushing Syndrome

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases