Growth Hormone Resistance of Beta-cells A | NCT06571487

Studies
Growth Hormone Resistance of Beta-cells A

NCT06571487

Sponsor

University of Missouri-Columbia

Status

Recruiting

Last Update Posted

May 11, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Gestational Diabetes
Obesity
Healthy

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

Status Module

Record Verification Date

Apr 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

Oct 22, 2025Actual

Primary Completion Date

Sep 1, 2028Estimated

Completion Date

Sep 1, 2030Estimated

First Submitted Date

Aug 22, 2024

First Submission Date that Met QC Criteria

Aug 22, 2024

First Posted Date

Aug 26, 2024Actual

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

May 5, 2026

Last Update Posted Date

May 11, 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

The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

30Estimated

Measure	Description	Time Frame
Beta-cell function	Insulin secretion rate in relationship to plasma glucose	before and 7 days after rhGH administration

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Singleton, full term pregnancy within the past 5 years
Body mass index ≥18.5 kg/m2 and <45.0 kg/m2

Group specific inclusion criteria:

Gestational Diabetes Group: History of gestational diabetes in the most recent pregnancy
Control Group: no history of gestational diabetes

Exclusion Criteria:

Pregnant, planning to become pregnant during the study, or breastfeeding
Current diagnosis or history of type 1 or type 2 diabetes
Use of medications that can impact the study outcomes (e.g., GLP-1 receptor agonists)
History of bariatric surgery
Known, uncontrolled hypothyroidism
History of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as Turner Syndrome, Prader-Willi Syndrome, or renal impairment
Current cancer or cancer that has been in remission less than 5 years
First degree relative with diabetes diagnosis
Evidence of significant anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease)
Alcohol use disorder, use of controlled substances, or smoking >2 cigarettes per day
Greater than 3% weight loss within three months of screening or engaged in regular (≥3 days per week), continuous moderate- or high-intensity exercise of ≥30 min duration
Mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

The study population will consist of women ages 18-45 with and without a history of gestational diabetes mellitus.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amanda Heider	Contact	573-884-6852		ahmc4@health.missouri.edu
Vasavi Shabrish, PhD	Contact			v.shabrish@missouri.edu

Overall Officials

Name	Affiliation	Role
Bettina Mittendorfer, PhD	University of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri School of Medicine	Recruiting	Columbia	Missouri	65212	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified data will be available upon reasonable request

Types

Not provided

Time Frame

5 years after completion of the study

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D009765	Obesity

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Women with a history of gestational diabetes mellitus
Women without a history of gestational diabetes mellitus