Gestational DiabetesGHRB-ANCT06571487
Growth Hormone Resistance of Beta-cells A
An observational study of Gestational Diabetes and Obesity, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Obesity, Healthy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to 1 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population will consist of women ages 18-45 with and without a history of gestational diabetes mellitus.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vasavi Shabrish, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri School of Medicine
Columbia, Missouri, 65212
Bettina Mittendorfer, 573-882-9377, b.mittendorfer@missouri.edu
About this study
Official title: Growth Hormone Resistance of Beta-cells in Women With Gestational Diabetes Mellitus
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.
- Conditions
- Gestational Diabetes, Obesity, Healthy
- Medical subject headings
- Diabetes, Gestational, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with a history of gestational diabetes mellitus | Not described | |
| Women without a history of gestational diabetes mellitus | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell function
Insulin secretion rate in relationship to plasma glucose
Measured: before and 7 days after rhGH administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start22 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bettina Mittendorfer, University of Missouri-Columbia
- Investigators
- Bettina Mittendorfer, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571487
- Sponsor's protocol ID
- 2111127-A
- Acronym
- GHRB-A
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2024
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Resistance of Beta-cells in Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06571487
- Acronym / sponsor ID
- GHRB-A / 2111127-A
- Conditions
- Gestational Diabetes, Obesity, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with a history of gestational diabetes mellitus | – | – |
| Women without a history of gestational diabetes mellitus | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will consist of women ages 18-45 with and without a history of gestational diabetes mellitus.
Key inclusion criteria (5 listed)
- Singleton, full term pregnancy within the past 5 years
- Body mass index ≥18.5 kg/m2 and <45.0 kg/m2
- Gestational Diabetes Group: History of gestational diabetes in the most recent pregnancy
- Control Group: no history of gestational diabetes
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beta-cell function
Time frame: before and 7 days after rhGH administration
Insulin secretion rate in relationship to plasma glucose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vasavi Shabrish, PhD contact
Bettina Mittendorfer, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Obesity, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Heider (573-884-6852, ahmc4@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-cell function (time frame: before and 7 days after rhGH administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.