AcromegalyNCT02084095
IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly
An observational study of Acromegaly, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I) correlates better with IR than growth hormone (GH). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acromegaly
- How many people
- 16 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2014to 1 Mar 2019
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will prospectively include patients with active acromegaly assessed in a tertiary center. All patients who meet inclusion and exclusion criteria will be invited consecutively to participate in the study until the proposed number of patients is reached.
Who may be able to join
- active acromegaly based on following criteria: minimum GH in oral glucose tolerance test (OGTT) over 1 ng/mL and serum IGF-I over upper limit of normal for age and sex
- age between 18 and 65 years old
Who cannot join
- more than one previous pituitary surgical intervention for acromegaly
- present medical treatment for acromegaly (somatostatin analogs, GH-receptor blockers, dopaminergic agonists)
- previous pituitary radiotherapy
- present medical treatment for hyperglycemia (oral antidiabetic drugs, insulin, etc)
- pituitary failure, treated or not
- medical or surgical conditions which, in the oppinion of the principal investigator, could impact on study results or patient's safety
- fasting blood glucose over 200 mg/dL or HbA1c over 8%.
- body mass index less than 20 or over 35 kg/mp
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Insulin-like Growth Factor-I (IGF-I) and Free Fatty Acids in Insulin Resistance, Insulin Secretion and Glucose Metabolism Abnormalities in Acromegaly
Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I) correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS is independent of acromegaly intensity.
The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.
Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test acording to Bergman model. FFA will be directly measured in plasma.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation coefficient between IGFBP-3 and insulin resistance assessed using Bergman model is non-inferior to the correlation coefficient between IGF-I and insulin resistance
Measured: 2 years
Free fatty acids correlates significantly with insulin resistance assessed using Bergman model
Measured: 2 years
Disposition index calculated using Bergman model is significantly reduced in subjects with glucose intolerance than in subjects with normal glucose tolerance
Measured: 2 years
Secondary outcomes (5)
GH, IGF-I and IGFBP-3 significantly correlates with insulin resistance calculated using Bergman model
Measured: 2 years
GH, IGF-I and IGFBP-3 significantly correlates with free fatty acids
Measured: 2 years
GH, IGF-I and IGFBP-3 does not correlate with insulin sensitivity calculated using Bergman model
Measured: 2 years
GH, IGF-I and IGFBP-3 does not correlate with disposition index
Measured: 2 years
Disposition index after reduction of acromegaly activity by various treatments
Measured: 3 months after surgery or start of medical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Niculescu, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084095
- Sponsor's protocol ID
- 28332
- Status last verified
- Aug 2019
- First submitted
- 7 Mar 2014
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Insulin-like Growth Factor-I (IGF-I) and Free Fatty Acids in Insulin Resistance, Insulin Secretion and Glucose Metabolism Abnormalities in Acromegaly
- ClinicalTrials.gov ID
- NCT02084095
- Acronym / sponsor ID
- 28332
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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.
Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I) correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS is independent of acromegaly intensity.
The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.
Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test acording to Bergman model. FFA will be directly measured in plasma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will prospectively include patients with active acromegaly assessed in a tertiary center. All patients who meet inclusion and exclusion criteria will be invited consecutively to participate in the study until the proposed number of patients is reached.
Key inclusion criteria (2 listed)
- active acromegaly based on following criteria: minimum GH in oral glucose tolerance test (OGTT) over 1 ng/mL and serum IGF-I over upper limit of normal for age and sex
- age between 18 and 65 years old
Key exclusion criteria (8 listed)
- more than one previous pituitary surgical intervention for acromegaly
- present medical treatment for acromegaly (somatostatin analogs, GH-receptor blockers, dopaminergic agonists)
- previous pituitary radiotherapy
- present medical treatment for hyperglycemia (oral antidiabetic drugs, insulin, etc)
- pituitary failure, treated or not
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
The correlation coefficient between IGFBP-3 and insulin resistance assessed using Bergman model is non-inferior to the correlation coefficient between IGF-I and insulin resistance
Time frame: 2 years
Free fatty acids correlates significantly with insulin resistance assessed using Bergman model
Time frame: 2 years
Disposition index calculated using Bergman model is significantly reduced in subjects with glucose intolerance than in subjects with normal glucose tolerance
Time frame: 2 years
5 secondary outcomes
GH, IGF-I and IGFBP-3 significantly correlates with insulin resistance calculated using Bergman model
Time frame: 2 years
GH, IGF-I and IGFBP-3 significantly correlates with free fatty acids
Time frame: 2 years
GH, IGF-I and IGFBP-3 does not correlate with insulin sensitivity calculated using Bergman model
Time frame: 2 years
GH, IGF-I and IGFBP-3 does not correlate with disposition index
Time frame: 2 years
Disposition index after reduction of acromegaly activity by various treatments
Time frame: 3 months after surgery or start of medical treatment
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 21 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acromegaly, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
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 2 inclusion and 8 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 21 Aug 2019. 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 Romania. 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?
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?
The correlation coefficient between IGFBP-3 and insulin resistance assessed using Bergman model is non-inferior to the correlation coefficient between IGF-I and insulin resistance (time frame: 2 years). The study lists 3 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 21 Aug 2019.