Insulin ResistancePhase 2NCT01354964
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
A Phase 2 study testing Vitamin D in people with Insulin Resistance, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2009to 3 Sep 2015
- Phase
- Phase 2
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Serum 25(OH)D<20ng/ml
- Insulin Resistant based on HOMA-IR score of >3
- Able and willing to provide informed consent
- BMI 20-35
Who cannot join
- HIV/AIDS
- History of any cancer
- Sarcoidosis
- Alcohol or substance abuse
- Cushing's syndrome
- Primary hyperparathyroidism
Show all 12Show fewer
- Nephrolithiasis
- Pregnancy or breastfeeding
- Regular visits to a tanning salon
- Hypercalcemia or hypocalcemia
- Untreated or uncontrolled hypertension
- Any chronic illness requiring medication, other than arthritis, hypertension and hyperlipidemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
The purpose of this research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.
Read the detailed description
Over the last several years, studies have shown that low vitamin D levels may increase risk of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels <20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue.
Investigators will study participants with a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Adipose tissue inflammation will be measured using the following inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.
- Conditions
- Insulin Resistance
- Being tested
- Vitamin D, Placebo
- Keywords
- Glucose Metabolism Disorders, Insulin Resistance, Endocrine System, Vitamin D
- Medical subject headings
- Insulin Resistance, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Vitamin D3 (cholecalciferol)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months. Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Hepatic Insulin Sensitivity
Endogenous glucose production (EGP) was assessed at each study visit to evaluate hepatic insulin sensitivity. Percent change between the EGP at baseline and second visit (after treatment for up to 3 months with Vitamin D to reach a target level of ≥30 ng/ml), and baseline and third visits (after treatment for up to 6 months with Vitamin D in order to reach a target level of ≥50 ng/ml) will be calculated.
Measured: 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months)
Secondary outcomes (5)
Percent Change in Peripheral Glucose Uptake
The rate of glucose uptake to determine peripheral insulin sensitivity was measured using the rate of disappearance (Rd) of glucose at each study visit. Percent change between the Rd at baseline and second visit (after treatment with Vitamin D for up to 3 months to target level of ≥30 ng/ml), and baseline and third visits (after treatment with Vitamin D for up to 6 months to target level of ≥50 ng/ml) will be calculated.
Measured: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene TNF-α
Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. TNF-α gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.
Measured: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene IL-6
Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. IL-6 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.
Measured: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene iNOS
Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. iNOS gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.
Measured: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene PAI-1
Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. PAI-1 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.
Measured: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study start13 Mar 2009
- Primary completion3 Jun 2015
- Study completion3 Sep 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.
- Other trials for Insulin ResistanceStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Meredith Hawkins, Albert Einstein College of Medicine
- Investigators
- Meredith A Hawkins, M.D., M.S., Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354964
- Sponsor's protocol ID
- 2008-225
- Other IDs
- 5K23RR023335-02
- Status last verified
- Oct 2020
- First submitted
- 12 May 2011
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT01354964
- Acronym / sponsor ID
- 2008-225
- Conditions
- Insulin Resistance
- Keywords
- Glucose Metabolism Disorders, Insulin Resistance, Endocrine System, Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- 13 Mar 2009 (actual)
- Primary completion
- 3 Jun 2015 (actual)
- Study completion
- 3 Sep 2015 (actual)
- First posted
- 17 May 2011 (estimated)
- Results
- Posted 9 Mar 2020
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 research is to study the effects of Vitamin D supplementation on the body's response to insulin (a hormone that controls blood sugar), on inflammation, and on specific cells and processes in fat tissue.
Detailed description
Over the last several years, studies have shown that low vitamin D levels may increase risk of developing Type 2 Diabetes. The investigators will administer vitamin D3 (cholecalciferol) to non-diabetic, insulin resistant subjects with vitamin D deficiency (total vitamin D levels <20 ng/ml) to increase the level of vitamin D3. The investigators will study the effects of increased Vitamin D on insulin action, adipose tissue inflammation, and on certain cells and processes in fat tissue.
Investigators will study participants with a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Adipose tissue inflammation will be measured using the following inflammatory markers: IL-6, PAI-1, TNF-alpha, and iNOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin DParticipants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Serum 25(OH)D<20ng/ml
- Insulin Resistant based on HOMA-IR score of >3
- Able and willing to provide informed consent
- BMI 20-35
Key exclusion criteria (12 listed)
- HIV/AIDS
- History of any cancer
- Sarcoidosis
- Alcohol or substance abuse
- Cushing's syndrome
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 |
|---|---|---|
| Vitamin DAlso: Vitamin D3 (cholecalciferol) | Drug | Vitamin D |
| Placebo | Drug | Placebo |
Primary outcome
Percent Change in Hepatic Insulin Sensitivity
Time frame: 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months)
Endogenous glucose production (EGP) was assessed at each study visit to evaluate hepatic insulin sensitivity. Percent change between the EGP at baseline and second visit (after treatment for up to 3 months with Vitamin D to reach a target level of ≥30 ng/ml), and baseline and third visits (after treatment for up to 6 months with Vitamin D in order to reach a target level of ≥50 ng/ml) will be calculated.
5 secondary outcomes
Percent Change in Peripheral Glucose Uptake
Time frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene TNF-α
Time frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene IL-6
Time frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene iNOS
Time frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Evaluated Expression of Pro-inflammatory Gene PAI-1
Time frame: 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Meredith A Hawkins, M.D., M.S. principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D in people with Insulin Resistance, run by Albert Einstein College of Medicine 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 4 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: finished, as of the sponsor's last update on 2 Nov 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2020). 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?
Percent Change in Hepatic Insulin Sensitivity (time frame: 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months)). 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 2 Nov 2020.