Type 1 DiabetesEDENNCT04418908
Estrogen, Diabetes, and Endothelial Function
A study testing Cetrorelix acetate, 0.25 mg/day and Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release in people with Type 1 Diabetes, run by University of Colorado, Denver.
Trial summary
This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure… 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
- Type 1 Diabetes
- What is being tested?
- Cetrorelix acetate, 0.25 mg/day and Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2010to 22 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Premenopausal
- Euthyroid
- Not currently planning to become pregnant
- Not currently breastfeeding
- No recent history of amenorrhea in the previous 6 months
- Consent to data and specimen banking
Show all 13Show fewer
- No use of hormonal contraceptives
- Diagnosis of type 1 diabetes for at least 5 years
- On insulin within a year of diagnosis
- Current insulin therapy
- Hemoglobin A1c < 9.5%
- No macroalbuminuria (AER < 200 ug/min)
- Hemoglobin A1c < 5.7%
Who cannot join
- Pregnant and/or breastfeeding
- Have not had a menstrual cycle in the last 6 months
About this study
Official title: Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes
This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.
Read the detailed description
Participants completed two study visits. The baseline study visit occurred during the early follicular phase of the menstrual cycle, confirmed via take-home ovulation testing. On the day of the baseline study visit, all participants underwent ovarian sex hormone suppression with GnRHant therapy (cetrorelix acetate, 0.25 mg/day) delivered daily as subcutaneous injections for a 1-week period. Participants were randomized to one of two concurrent intervention groups: transdermal estradiol patch (0.075 mg/day) (+E2) or placebo patch (+PL) and returned for a follow-up visit after 1 week of the intervention. Both study visits included collection of anthropometric measures, a fasting blood sample, measures of arterial stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.
- Conditions
- Type 1 Diabetes
- Being tested
- Cetrorelix acetate, 0.25 mg/day, Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release, Placebo patch
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix acetate, 0.25 mg/dayDrug
Also called Cetrotide, GnRHant
All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).
Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended ReleaseDrug
Also called Climara
Active estradiol transdermal patch.
Placebo patchDrug
Placebo patch designed to match active Climara patches.
| Study group | Role | What they receive |
|---|---|---|
| GnRHant + E2 | Active comparator | Participants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week. Receives: Drug: Cetrorelix acetate, 0.25 mg/day; Drug: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release |
| GnRHant + PL | Placebo comparator | Participants in this arm received GnRHant and a placebo patch for a period of 1 week. Receives: Drug: Cetrorelix acetate, 0.25 mg/day; Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation (FMD) at baseline
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Measured: 1 week
Flow-mediated dilation (FMD) at follow-up
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Measured: 1 week
Change in flow-mediated dilation (FMD)
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion at baseline and follow-up.
Measured: Baseline and 1 week
Quantitative immunuofluorescence of endothelial cell proteins at baseline
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Measured: Baseline
Quantitative immunuofluorescence of endothelial cell proteins at follow-up
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Measured: 1 week
Change in quantitative immunuofluorescence of endothelial cell proteins
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start24 Nov 2010
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to either receiving a gonadotropin-releasing antagonist (GnRHant) with estradiol add-back (+E2) or placebo (+PL). Investigators and participants were blinded to randomization status until the study was completed.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janet K Snell-Bergeon, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418908
- Sponsor's protocol ID
- 10-0591
- Acronym
- EDEN
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Disease, Inflammation and Hormones in Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04418908
- Acronym / sponsor ID
- EDEN / 10-0591
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 24 Nov 2010 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 5 Jun 2020 (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.
This study planned to learn more about women and how the drop in estradiol levels during menopause may affect their cardiovascular risk. With aging, the arteries that are located around the heart get stiffer, and this increase in arterial stiffness can lead to a number of health problems such as high blood pressure and heart disease. In this study, the investigators examined whether a short-term drop in estrogen levels caused arteries to become stiffer, and explored potential reasons for stiffening arteries.
Detailed description
Participants completed two study visits. The baseline study visit occurred during the early follicular phase of the menstrual cycle, confirmed via take-home ovulation testing. On the day of the baseline study visit, all participants underwent ovarian sex hormone suppression with GnRHant therapy (cetrorelix acetate, 0.25 mg/day) delivered daily as subcutaneous injections for a 1-week period. Participants were randomized to one of two concurrent intervention groups: transdermal estradiol patch (0.075 mg/day) (+E2) or placebo patch (+PL) and returned for a follow-up visit after 1 week of the intervention. Both study visits included collection of anthropometric measures, a fasting blood sample, measures of arterial stiffness, flow-mediated dilation, and endothelial cells via an intravenous catheter.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized to either receiving a gonadotropin-releasing antagonist (GnRHant) with estradiol add-back (+E2) or placebo (+PL). Investigators and participants were blinded to randomization status until the study was completed.
| Arm | Type | Receives |
|---|---|---|
| GnRHant + E2 | Active comparator | Drug: Cetrorelix acetate, 0.25 mg/day, Drug: Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended ReleaseParticipants in this arm received GnRHant and a transdermal estradiol patch (0.075 mg/day) for a period of 1 week. |
| GnRHant + PL | Placebo comparator | Drug: Cetrorelix acetate, 0.25 mg/day, Drug: Placebo patchParticipants in this arm received GnRHant and a placebo patch for a period of 1 week. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Premenopausal
- Euthyroid
- Not currently planning to become pregnant
- Not currently breastfeeding
- No recent history of amenorrhea in the previous 6 months
Key exclusion criteria (2 listed)
- Pregnant and/or breastfeeding
- Have not had a menstrual cycle in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetrorelix acetate, 0.25 mg/dayAlso: Cetrotide, GnRHantAll participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day). | Drug | GnRHant + E2, GnRHant + PL |
| Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended ReleaseAlso: ClimaraActive estradiol transdermal patch. | Drug | GnRHant + E2 |
| Placebo patchPlacebo patch designed to match active Climara patches. | Drug | GnRHant + PL |
Primary outcome
Flow-mediated dilation (FMD) at baseline
Time frame: 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Flow-mediated dilation (FMD) at follow-up
Time frame: 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion.
Change in flow-mediated dilation (FMD)
Time frame: Baseline and 1 week
FMD will be measured following an intravenous saline infusion and ascorbic acid infusion at baseline and follow-up.
Quantitative immunuofluorescence of endothelial cell proteins at baseline
Time frame: Baseline
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Quantitative immunuofluorescence of endothelial cell proteins at follow-up
Time frame: 1 week
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Change in quantitative immunuofluorescence of endothelial cell proteins
Time frame: Baseline and 1 week
Expression of estrogen receptor alpha, estrogen receptor beta, endothelial nitric oxide synthase, and phosphorylated endothelial nitric oxide synthase in endothelial cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
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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. This study is not recruiting at the moment.
Janet K Snell-Bergeon, PhD, MPH principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Cetrorelix acetate, 0.25 mg/day and Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release in people with Type 1 Diabetes, run by University of Colorado, Denver.
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 13 inclusion and 2 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: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-mediated dilation (FMD) at baseline (time frame: 1 week). The study lists 6 primary outcomes in all. 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 5 Jun 2020.