Type 2 DiabetesVALIDATE-DNCT01635062
The VALIDATE-D Study
A study testing Calcitriol in people with Type 2 Diabetes and Obesity, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Calcitriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
- Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
- Age >18 years and <70 years
- Estimated GFR > 60ml/min
- Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
- Electrocardiogram without any signs of prior infarction, ventricular conduction abnormality, or supraventricular arrhythmia.
Who cannot join
- Chronic Kidney Disease or eGFR<60
- History of nephrolithiasis (kidney stones)
- Multiple (more than one) insulin injections daily (since insulin can alter the RAS)
- Poorly controlled type 2 diabetes (That may require more aggressive therapy) as defined by an HbA1c>8.5%
- Type 1 diabetes
- Stage 2 or Stage 3 hypertension or the use of more than 1 antihypertensive drug
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- Chronic inflammatory conditions (such as inflammatory bowel disease or arthritis) that are treated with prescribed doses of NSAIDs by a physician.
- The use of prescribed doses of potassium supplements.
- History of liver failure
- History of parathyroid or granulomatous disorders
- History of heart failure, cerebrovascular disease or coronary heart disease
- History of known microvascular complications of diabetes (including retinopathy, neuropathy, nephropathy)
- Illness requiring overnight hospitalization in the past 6 months
- Active tobacco or recreational drug use
- Pregnancy or current breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Evaluating Hormonal Mechanisms for Vitamin D Receptor Agonist Therapy in Diabetes: The VALIDATE-D Study
The purpose of this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.
Read the detailed description
This study aims to evaluate whether vitamin D receptor agonist therapy (calcitriol) in diabetes lowers renin-angiotensin system (RAS) activity in a manner similar to an ACE inhibitor. This is a physiology study, focused on evaluating hormonal changes in the circulating and tissue RAS when compared to placebo.
Subjects with type 2 diabetes and obesity and normal kidney function will undergo evaluation of their circulating and renal-vascular RAS activity and urinary protein at baseline, after withdrawing interfering medications, while on a controlled electrolyte diet, and in controlled posture settings. They will then randomly receive a study medication (calcitriol or placebo) for 3 weeks followed by a re-assessment of their RAS parameters. The main outcomes that will be evaluated following calcitriol/placebo include measures of the circulating renin activity (primary), as well as measures of the renal-vascular RAS (renal plasma flow) and urine protein (secondary)
The primary outcome is the change in the plasma renin activity when sodium restricted, before and after intervention. Secondary outcomes include the change in renal plasma flow and urine protein when sodium loaded, before and after intervention.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Calcitriol, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called 1,25-dihydroxyvitamin D3
Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.
PlaceboDrug
Subjects will receive placebo for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| calcitriol | Experimental | Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks. Receives: Drug: Calcitriol |
| placebo | Placebo comparator | Subjects will receive placebo for 3 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy
The below results represent the change in Plasma Renin Activity.
Measured: baseline and 2 weeks following calcitriol/placebo therapy
Secondary outcomes (2)
Change in Renal Plasma Flow After Calcitriol/Placebo Therapy
Subjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.
Measured: baseline and 3 weeks following calcitriol/placebo therapy
Change in Urine Protein After Calcitriol/Placebo Therapy
Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.
Measured: baseline and 3 weeks following calcitriol/placebo therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anand Vaidya, Brigham and Women's Hospital
- Investigators
- Anand Vaidya, MD, MMSc, Principal investigator, Brigham and Women's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635062
- Sponsor's protocol ID
- 2012P000905
- Acronym
- VALIDATE-D
- Status last verified
- Feb 2017
- First submitted
- 2 Jul 2012
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brown JM, Secinaro K, Williams JS, Vaidya A. Evaluating hormonal mechanisms of vitamin D receptor agonist therapy in diabetic kidney disease: the VALIDATE-D study. BMC Endocr Disord. 2013 Aug 23;13:33. doi: 10.1186/1472-6823-13-33.
PubMed 23971740
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Hormonal Mechanisms for Vitamin D Receptor Agonist Therapy in Diabetes: The VALIDATE-D Study
- ClinicalTrials.gov ID
- NCT01635062
- Acronym / sponsor ID
- VALIDATE-D / 2012P000905
- Conditions
- Type 2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Posted 11 Apr 2017
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 this study is to evaluate whether vitamin D receptor agonist therapy lowers renin-angiotensin system activity.
Detailed description
This study aims to evaluate whether vitamin D receptor agonist therapy (calcitriol) in diabetes lowers renin-angiotensin system (RAS) activity in a manner similar to an ACE inhibitor. This is a physiology study, focused on evaluating hormonal changes in the circulating and tissue RAS when compared to placebo.
Subjects with type 2 diabetes and obesity and normal kidney function will undergo evaluation of their circulating and renal-vascular RAS activity and urinary protein at baseline, after withdrawing interfering medications, while on a controlled electrolyte diet, and in controlled posture settings. They will then randomly receive a study medication (calcitriol or placebo) for 3 weeks followed by a re-assessment of their RAS parameters. The main outcomes that will be evaluated following calcitriol/placebo include measures of the circulating renin activity (primary), as well as measures of the renal-vascular RAS (renal plasma flow) and urine protein (secondary)
The primary outcome is the change in the plasma renin activity when sodium restricted, before and after intervention. Secondary outcomes include the change in renal plasma flow and urine protein when sodium loaded, before and after intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcitriol | Experimental | Drug: CalcitriolSubjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks. |
| placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo for 3 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type-Two Diabetes (treated with diet alone, with oral hypoglycemic agents, or with a single injection of basal insulin daily)
- Normal blood pressure, or Mild (Stage 1) Hypertension that is either untreated, or adequately treated with a single anti-hypertensive drug.
- Age >18 years and <70 years
- Estimated GFR > 60ml/min
- Normal laboratory values for: Complete blood count, sodium, potassium, glucose, liver enzymes, urinalysis
Key exclusion criteria (15 listed)
- Chronic Kidney Disease or eGFR<60
- History of nephrolithiasis (kidney stones)
- Multiple (more than one) insulin injections daily (since insulin can alter the RAS)
- Poorly controlled type 2 diabetes (That may require more aggressive therapy) as defined by an HbA1c>8.5%
- Type 1 diabetes
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 |
|---|---|---|
| CalcitriolAlso: 1,25-dihydroxyvitamin D3Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks. | Drug | calcitriol |
| PlaceboSubjects will receive placebo for 3 weeks. | Drug | placebo |
Primary outcome
The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy
Time frame: baseline and 2 weeks following calcitriol/placebo therapy
The below results represent the change in Plasma Renin Activity.
2 secondary outcomes
Change in Renal Plasma Flow After Calcitriol/Placebo Therapy
Time frame: baseline and 3 weeks following calcitriol/placebo therapy
Change in Urine Protein After Calcitriol/Placebo Therapy
Time frame: baseline and 3 weeks following calcitriol/placebo therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23971740Brown JM, Secinaro K, Williams JS, Vaidya A. Evaluating hormonal mechanisms of vitamin D receptor agonist therapy in diabetic kidney disease: the VALIDATE-D study. BMC Endocr Disord. 2013 Aug 23;13:33. doi: 10.1186/1472-6823-13-33.
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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.
Anand Vaidya, MD, MMSc principal investigator
Brigham and Women's Hospital, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcitriol in people with Type 2 Diabetes and Obesity, run by Brigham and Women's Hospital 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 6 inclusion and 15 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 11 Apr 2017. 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. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Change in Circulating RAS Activity After Calcitriol/Placebo Therapy (time frame: baseline and 2 weeks following calcitriol/placebo therapy). 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 NCT01635062, which also lists 1 linked publication.
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 Apr 2017.