NCT03761290

Brief Summary

It is increasingly recognized that Pseudohypoparathyroidism type 1A (PHP1A) is associated with an increased risk of type 2 diabetes but the mechanism is unknown. In this pilot study we will assess β-cell function in patients with PHP1A and pseudopseudohypoparathyroidism PPHP.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

June 19, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

November 29, 2018

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity (Si)

    baseline

Study Arms (3)

Pseudphypoparathyroidism type 1A (PHP1A)

Case

Pseudopseudohypoparathyroidism (PPHP)

Case

Controls

Matched control group

Eligibility Criteria

Age6 Years - 50 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with PHP1A/PPHP and matched controls

You may qualify if:

  • Diagnosis of PHP1A/PPHP
  • Age between 6 and 50 years old
  • Controls will be matched based on:
  • Gender
  • Race
  • Age (±2 years if \<25 years old or ±5 years if ≥25 years old)
  • BMI (±2 kg/m2)
  • Diabetes status

You may not qualify if:

  • Treatment with appetite-altering drug or initiation of a new weight loss program in the past 3 months
  • Type 1 diabetes
  • Type 2 diabetes treated with insulin or GLP-1 receptor agonists or A1c \>9%at their most recent clinic visit
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • Perez KM, Curley KL, Slaughter JC, Shoemaker AH. Glucose Homeostasis and Energy Balance in Children With Pseudohypoparathyroidism. J Clin Endocrinol Metab. 2018 Nov 1;103(11):4265-4274. doi: 10.1210/jc.2018-01067.

    PMID: 30085125BACKGROUND

Related Links

MeSH Terms

Conditions

PseudohypoparathyroidismPseudopseudohypoparathyroidism

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism Disorders

Study Officials

  • Ashley H Shoemaker, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 3, 2018

Study Start

June 19, 2019

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations