Complications of Transplanted Organs and TissuePhase 4CSATACNCT00766909
Diabetogenicity of Cyclosporine and Tacrolimus
A Phase 4 study testing cyclosporine, tacrolimus and Capsules and isotonic saline in people with Complications of Transplanted Organs and Tissue and Diabetes Mellitus Nos New Onset, run by University of Aarhus at 1 site in Denmark.
Trial summary
Cyclosporine (CsA) and Tacrolimus (Tac) are immunosuppressive agents comprising the cornerstone of treatment among organ transplant recipients. Unfortunately diabetes is a known complication after transplantation, yet the underlying mechanisms of this type of diabetes are still unresolved. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complications of Transplanted Organs and Tissue, Diabetes Mellitus Nos New Onset
- What is being tested?
- cyclosporine, tacrolimus and Capsules and isotonic saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Nov 2011
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (Study 1):
- Men.
- Age between 18 years and 50 years. Upper limit can be +2 years if approved by main investigator.
- Normal OGTT (0 and 120 min test).
- Body mass index (BMI) 20 - 30 kg/m2. Allowed variations are 5% from the upper and lower limit.
- Normal serum creatinine and ionisized calcium. Allowed variations are 20% from the upper and lower limit of the normal value for creatinine and 5% for calcium.
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- Normal urine stix
- Written consent to participate.
- Hemodialysis Patients (study 2):
- Age between 18 years and 70 years. Upper limit can be +2 years if approved by main investigator.
- BMI < 30 kg/m2. Allowed variations are 5% over the upper limit.
- On the waiting-list for a kidney transplant.
- Haemodialysis candidate.
- Anti-conceptive treatment (contraceptive pill/intrauterine device/patch/ring/ implant/injectable contraceptive) if the patient is a fertile woman.
- Written consent to participate. -
Who cannot join
- Healthy volunteers (Study 1):
- Anaemia with haemoglobin levels < 7 mmol/L
- Participation in any other clinical trial.
- Subjects who cannot adhere to test conditions.
- Anamnesis of clinically significant disease, such as:
- liver disease
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- kidney disease,
- neurological disease
- gastrointestinal disease
- haematological disease
- endocrine disease
- lung disease
- cardiac disease
- Drug or alcohol abuse, which would render the subject unfit according to the main investigator.
- Blood donation 1 month prior to the study day
- Patients with established allergy against CI or other medical products, which might pose a risk if they participated in this study.
- Use of prescription drugs within one month prior to the study days, unless they are clinically insignificant according to the main investigator.
- Smoking 8 hours prior to the study day
- Vigorous exercise 30 minutes prior to the study day.
- Hemodialysis Patients (study 2):
- Peritoneal dialysis.
- Anaemia with haemoglobin levels < 6 mmol/L.
- Participation in any other clinical trial.
- Treatment with corticosteroids, CsA or Tac.
- Patients who cannot adhere to test conditions.
- Patients with established allergy against CI or other medical product, which might pose a risk if they participated in this study.
- Drug or alcohol abuse, which would render the subject unfit according to the main investigator.
- Anamnesis of current diabetes and/or intake of anti-diabetic medication.
- Malignancy.
- Uncontrolled infection.
- Uncontrolled hypertension.
- Smoking 8 hours prior to the study day.
- Vigorous exercise 30 minutes prior to the study day
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus, Jutland, 8200
About this study
Cyclosporine (CsA) and Tacrolimus (Tac) are immunosuppressive agents comprising the cornerstone of treatment among organ transplant recipients. Unfortunately diabetes is a known complication after transplantation, yet the underlying mechanisms of this type of diabetes are still unresolved. A direct comparison of the diabetogenic effects of CsA and Tac, without interference of corticosteroid treatment, has not yet been investigated using a hyperinsulinemic euglycemic glucose clamp technique, which is the best method for estimating insulin sensitivity.
Randomized, investigator-blinded cross-over studies will be carried out, studying 10 healthy subjects and 10 hemodialysis patients. Each participant will receive treatment with CsA, Tac and placebo respectively in a random order. The results will be of relevance to the choice and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the development of better treatment modalities for diabetes.
Read the detailed description
Background: Post-transplantation diabetes mellitus (PTDM) is a complication of the calcineurin inhibitors (CI) cyclosporine (CsA) and Tacrolimus (Tac), but much controversy still exists regarding the mechanism leading to this disorder. Several studies using intravenous (IVGTT) or oral glucose tolerance tests have shown that CsA and Tac tend to reduce insulin release, while corticosteroids increase insulin resistance. Decreased insulin secretion may be the result of beta-cell toxicity, apoptosis or inhibition of calcineurin signaling cessating insulin gene transcription. Comparing the drug using IVGTT has shown that long-term glucose metabolism is not significantly different between the two. Reviewing the literature brings forth that some of these data and the observed higher incidence of PTDM in Tac-treated recipients are conflicting.
To or knowledge, comparison of the diabetogenic effects of CsA and Tac, without concomitant corticosteroids, has never been investigated using the gold standard to estimate insulin sensitivity; a hyperinsulinemic euglycemic glucose clamp (HEGC).
Hypotheses: CsA and Tac are able to induce diabetes, by exerting acute and chronic effects on pancreas beta-cell performance and insulin sensitivity.
The hypothesized effects will be investigated during following studies:
- Acute effect in 10 healthy subjects undergoing HEGC
- Chronic effect in 10 pre-transplant uremic patients undergoing HEGC
Methods: The studies are randomized, double-blinded (Study 1) and investigator blinded (Study 2) cross-over designs. Each study subject participates in three experimental study days with an interval of 4-6 weeks. A HEGC is carried out on the study days, where treatment includes CsA, Tac and placebo respectively in random order. Following an overnight fast the healthy subject / uremic patient arrives in the research laboratory, where a catheter is implanted in each arm for blood sampling and infusion purposes.
Pulse induction: Glucose 6 mg/kg/min is infused every 10 minutes followed by a 9 minute pause. From 30 to 90 min blood is drawn every minute for insulin and every 10th minute for glucose measurements.
First phase insulin secretion: After 120 minutes glucose 0.3 g/kg (maximally 25 g) is infused over 2 min and the catheter is flushed with 50 ml of isotonic saline. Insulin, glucose and c-peptide are measured with a few minutes intervals.
Insulin infusion/HEGC: 1.0 mU/kg/min insulin infusion is initiated at the 165th minute and blood glucose levels are kept at 5.0 mmol/L, using variable infusion of a 20% glucose dilution throughout the following 120 minutes. The final 30 min of the clamp is considered the hyperinsulinaemic steady state period. Aside from glucose, insulin and other endocrinological parameters, measurements of drug concentration and CaN will also be performed.
Perspectives: The studies are expected to give valuable insight into the diabetogenic effects of CI, and to show whether or not CsA and Tac are comparable in their Diabetogenicity. The results will be of relevance to the choice and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the development of better treatment modalities for diabetes.
- Being tested
- cyclosporine, tacrolimus, Capsules and isotonic saline
- Keywords
- Insulin pulsatility, Insulin secretion, Insulin sensitivity, Calcineurin inhibitor, Cyclosporine, Tacrolimus
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporineDrug
Also called Sandimmun
For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.155 mg/kg over a maximum duration of 5 hours.
For Dialysis Patients (study 2): Oral intake of 4 mg/kg 2 times daily for 8-11 days.
tacrolimusDrug
Also called Prograf
For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.0012 mg/kg over a maximum duration of 5 hours.
For Dialysis Patients (study 2): Oral intake of 0.1 mg/kg 2 times daily for 8-11 days.
Capsules and isotonic salineOther
Also called Saline, NaCl
For Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.06 ml/kg isotonic saline over a maximum duration of 5 hours.
For Dialysis patients (study 2): Placebo capsules 2 times daily for 8-11 days.
| Study group | Role | What they receive |
|---|---|---|
| CsA | Experimental | Cyclosporine Receives: Drug: cyclosporine |
| Tac | Experimental | Tacrolimus Receives: Drug: tacrolimus |
| Placebo | Placebo comparator | placebo/saline Receives: Other: Capsules and isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Measured: Serial measurements during 120 minute Hyperinsulinemic euglycemic clamp investigation. Performed 3 times on 3 individual days within 4 months after inclusion
Secondary outcomes (9)
insulin secretion
Measured: Serial measurements during IVGTT. Performed 3 times on 3 individual days within 4 months after inclusion.
serum free fatty acids
Measured: Serial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
serum C-peptide
Measured: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
blood cyclosporine
Measured: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
blood tacrolimus
Measured: Serial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
respiratory gas exchange, substrate metabolism
Measured: Indirect calorimetry performed 3 times on 3 individual days within 4 months after inclusion.
Pulsatile Insulin secretion
Measured: erial measurements during glucose entrainment. Performed 3 times on 3 individual days within 4 months after inclusion.
plasma Glucose
Measured: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
plasma glucagon
Measured: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complications of Transplanted Organs and TissueStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara Aygen Øzbay, MD, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766909
- Sponsor's protocol ID
- M-20080060
- Acronym
- CSATAC
- Status last verified
- Nov 2011
- First submitted
- 3 Oct 2008
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ozbay LA, Stubbe J, Jespersen B, Jensen BL. The effects of calcineurin inhibitors on prostanoid synthesis: a randomized cross-over study in healthy humans. Transpl Int. 2013 Feb;26(2):131-7. doi: 10.1111/tri.12004. Epub 2012 Nov 29.
PubMed 23190385Ozbay LA, Moller N, Juhl C, Bjerre M, Carstens J, Rungby J, Jorgensen KA. The impact of calcineurin inhibitors on insulin sensitivity and insulin secretion: a randomized crossover trial in uraemic patients. Diabet Med. 2012 Dec;29(12):e440-4. doi: 10.1111/dme.12028.
PubMed 23003106
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetogenicity of Cyclosporine and Tacrolimus
- ClinicalTrials.gov ID
- NCT00766909
- Acronym / sponsor ID
- CSATAC / M-20080060
- Keywords
- Insulin pulsatility, Insulin secretion, Insulin sensitivity, Calcineurin inhibitor, Cyclosporine, Tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Oct 2008 (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.
Cyclosporine (CsA) and Tacrolimus (Tac) are immunosuppressive agents comprising the cornerstone of treatment among organ transplant recipients. Unfortunately diabetes is a known complication after transplantation, yet the underlying mechanisms of this type of diabetes are still unresolved. A direct comparison of the diabetogenic effects of CsA and Tac, without interference of corticosteroid treatment, has not yet been investigated using a hyperinsulinemic euglycemic glucose clamp technique, which is the best method for estimating insulin sensitivity.
Randomized, investigator-blinded cross-over studies will be carried out, studying 10 healthy subjects and 10 hemodialysis patients. Each participant will receive treatment with CsA, Tac and placebo respectively in a random order. The results will be of relevance to the choice and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the development of better treatment modalities for diabetes.
Detailed description
Background: Post-transplantation diabetes mellitus (PTDM) is a complication of the calcineurin inhibitors (CI) cyclosporine (CsA) and Tacrolimus (Tac), but much controversy still exists regarding the mechanism leading to this disorder. Several studies using intravenous (IVGTT) or oral glucose tolerance tests have shown that CsA and Tac tend to reduce insulin release, while corticosteroids increase insulin resistance. Decreased insulin secretion may be the result of beta-cell toxicity, apoptosis or inhibition of calcineurin signaling cessating insulin gene transcription. Comparing the drug using IVGTT has shown that long-term glucose metabolism is not significantly different between the two. Reviewing the literature brings forth that some of these data and the observed higher incidence of PTDM in Tac-treated recipients are conflicting.
To or knowledge, comparison of the diabetogenic effects of CsA and Tac, without concomitant corticosteroids, has never been investigated using the gold standard to estimate insulin sensitivity; a hyperinsulinemic euglycemic glucose clamp (HEGC).
Hypotheses: CsA and Tac are able to induce diabetes, by exerting acute and chronic effects on pancreas beta-cell performance and insulin sensitivity.
The hypothesized effects will be investigated during following studies:
- Acute effect in 10 healthy subjects undergoing HEGC
- Chronic effect in 10 pre-transplant uremic patients undergoing HEGC
Methods: The studies are randomized, double-blinded (Study 1) and investigator blinded (Study 2) cross-over designs. Each study subject participates in three experimental study days with an interval of 4-6 weeks. A HEGC is carried out on the study days, where treatment includes CsA, Tac and placebo respectively in random order. Following an overnight fast the healthy subject / uremic patient arrives in the research laboratory, where a catheter is implanted in each arm for blood sampling and infusion purposes.
Pulse induction: Glucose 6 mg/kg/min is infused every 10 minutes followed by a 9 minute pause. From 30 to 90 min blood is drawn every minute for insulin and every 10th minute for glucose measurements.
First phase insulin secretion: After 120 minutes glucose 0.3 g/kg (maximally 25 g) is infused over 2 min and the catheter is flushed with 50 ml of isotonic saline. Insulin, glucose and c-peptide are measured with a few minutes intervals.
Insulin infusion/HEGC: 1.0 mU/kg/min insulin infusion is initiated at the 165th minute and blood glucose levels are kept at 5.0 mmol/L, using variable infusion of a 20% glucose dilution throughout the following 120 minutes. The final 30 min of the clamp is considered the hyperinsulinaemic steady state period. Aside from glucose, insulin and other endocrinological parameters, measurements of drug concentration and CaN will also be performed.
Perspectives: The studies are expected to give valuable insight into the diabetogenic effects of CI, and to show whether or not CsA and Tac are comparable in their Diabetogenicity. The results will be of relevance to the choice and monitoring of immunosuppressive regimens in kidney transplant recipients as well as the development of better treatment modalities for diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CsA | Experimental | Drug: cyclosporineCyclosporine |
| Tac | Experimental | Drug: tacrolimusTacrolimus |
| Placebo | Placebo comparator | Other: Capsules and isotonic salineplacebo/saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Men.
- Age between 18 years and 50 years. Upper limit can be +2 years if approved by main investigator.
- Normal OGTT (0 and 120 min test).
- Body mass index (BMI) 20 - 30 kg/m2. Allowed variations are 5% from the upper and lower limit.
- Normal serum creatinine and ionisized calcium. Allowed variations are 20% from the upper and lower limit of the normal value for creatinine and 5% for calcium.
Key exclusion criteria (34 listed)
- Anaemia with haemoglobin levels < 7 mmol/L
- Participation in any other clinical trial.
- Subjects who cannot adhere to test conditions.
- Anamnesis of clinically significant disease, such as:
- Drug or alcohol abuse, which would render the subject unfit according to the main investigator.
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 |
|---|---|---|
| cyclosporineAlso: SandimmunFor Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.155 mg/kg over a maximum duration of 5 hours. For Dialysis Patients (study 2): Oral intake of 4 mg/kg 2 times daily for 8-11 days. | Drug | CsA |
| tacrolimusAlso: PrografFor Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.0012 mg/kg over a maximum duration of 5 hours. For Dialysis Patients (study 2): Oral intake of 0.1 mg/kg 2 times daily for 8-11 days. | Drug | Tac |
| Capsules and isotonic salineAlso: Saline, NaClFor Healthy volunteers (study 1) and Dialysis patients (study 2): Single intravenous infusion of 0.06 ml/kg isotonic saline over a maximum duration of 5 hours. For Dialysis patients (study 2): Placebo capsules 2 times daily for 8-11 days. | Other | Placebo |
Primary outcome
Insulin Sensitivity
Time frame: Serial measurements during 120 minute Hyperinsulinemic euglycemic clamp investigation. Performed 3 times on 3 individual days within 4 months after inclusion
9 secondary outcomes
insulin secretion
Time frame: Serial measurements during IVGTT. Performed 3 times on 3 individual days within 4 months after inclusion.
serum free fatty acids
Time frame: Serial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
serum C-peptide
Time frame: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
blood cyclosporine
Time frame: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
blood tacrolimus
Time frame: Serial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
respiratory gas exchange, substrate metabolism
Time frame: Indirect calorimetry performed 3 times on 3 individual days within 4 months after inclusion.
Pulsatile Insulin secretion
Time frame: erial measurements during glucose entrainment. Performed 3 times on 3 individual days within 4 months after inclusion.
plasma Glucose
Time frame: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
plasma glucagon
Time frame: erial measurements during 5-hour infusions of CsA, Tac or saline. Performed 3 times on 3 individual days within 4 months after inclusion.
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 8 Nov 2011.
- Derived from this study: PubMed 23190385Ozbay LA, Stubbe J, Jespersen B, Jensen BL. The effects of calcineurin inhibitors on prostanoid synthesis: a randomized cross-over study in healthy humans. Transpl Int. 2013 Feb;26(2):131-7. doi: 10.1111/tri.12004. Epub 2012 Nov 29.
- Derived from this study: PubMed 23003106Ozbay LA, Moller N, Juhl C, Bjerre M, Carstens J, Rungby J, Jorgensen KA. The impact of calcineurin inhibitors on insulin sensitivity and insulin secretion: a randomized crossover trial in uraemic patients. Diabet Med. 2012 Dec;29(12):e440-4. doi: 10.1111/dme.12028.
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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.
Lara Aygen Øzbay, MD principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cyclosporine, tacrolimus and Capsules and isotonic saline in people with Complications of Transplanted Organs and Tissue and Diabetes Mellitus Nos New Onset, run by University of Aarhus at 1 site in Denmark.
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 15 inclusion and 34 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 8 Nov 2011. 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 Denmark. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin Sensitivity (time frame: Serial measurements during 120 minute Hyperinsulinemic euglycemic clamp investigation. Performed 3 times on 3 individual days within 4 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00766909, which also lists 2 linked publications.
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 8 Nov 2011.