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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23RR023335-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months. |
|
| Placebo | Placebo Comparator | Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meredith A Hawkins, M.D., M.S. | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D | Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to 6 months. . |
| FG001 | Placebo | Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D | Participants received weekly oral vitamin D drops using a weight-based calculated dosage for up to six months. . |
| BG001 | Placebo | Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D) for up to six months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Hepatic insulin sensitivity was measured in 7 (out of 11) participants in the Vitamin D group and in 7 (out of 8) participants in the placebo group at the 3rd study visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. | Posted | Mean | Standard Error | percent change | 2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months) |
|
Time enrolled in study (approximately 6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D | Participants in this group were assigned to receive weekly oral vitamin D drops using a weight-based calculated dosage for six months. . |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| benign paroxysmal vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pre-syncopal episode | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meredith Hawkins | Albert Einstein College of Medicine | 7184302903 | 2903 | meredith.hawkins@einsteinmed.org |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Drug |
|
| 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. | 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. | 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. | 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. | 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) |
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hepatic Insulin Sensitivity | We examine the endogenous glucose production (EGP) to assess hepatic insulin sensitivity at baseline. | Mean | Standard Deviation | mg/kg/min |
|
| Peripheral Glucose Uptake | We examine the rate of glucose uptake to determine peripheral insulin sensitivity using rate of disappearance (Rd) of glucose. | Mean | Standard Deviation | mg/kg/min |
|
| Evaluated expression of pro-inflammatory gene TNF-α in macrophages | 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 polymerase chain reaction (rt-PCR) and will provide a measure of macrophage activation. 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. | TNFα was measured in 6 participants in placebo group. | Mean | Standard Deviation | Ratio of mRNA copy numbers (TNF-α/5HKGs) |
|
| Evaluated expression of pro-inflammatory gene IL-6 in macrophages | 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 polymerase chain reaction (rt-PCR) and will provide a measure of macrophage activation. 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. | IL-6 was measured in 6 participants in placebo group. | Mean | Standard Deviation | Ratio of mRNA copy numbers (IL-6/5HKGs) |
|
| Evaluated expression of pro-inflammatory gene iNOS in macrophages | 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 polymerase chain reaction (rt-PCR) and will provide a measure of macrophage activation. 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. | iNOS was measured in 6 participants in placebo group. | Mean | Standard Deviation | Ratio of mRNA copy numbers (iNOS/5HKGs) |
|
| Evaluated expression of pro-inflammatory gene PAI-1 in macrophages | 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 polymerase chain reaction (rt-PCR) and will provide a measure of macrophage activation. 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. | PAI-1 was measured in 6 participants in placebo group. | Mean | Standard Deviation | Ratio of mRNA copy numbers (PAI-1/5HKGs) |
|
| OG001 | Placebo | Participants received weekly oral placebo drops (similar in taste and appearance to vitamin D). |
|
|
| Secondary | 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. | Hepatic insulin sensitivity was measured in 7 (out of 11) participants in the Vitamin D group and in 6 (out of 8) participants in the placebo group at the 3rd study visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. | Posted | Mean | Standard Error | percent change | 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) |
|
|
|
| Secondary | 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. | TNF-α expression was measured in 7 (out of 11) participants in the Vitamin D group and in 4 (out of 8) participants in the placebo group at the 3rd study visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. Additionally, 2 participants in placebo group did not provide fat biopsy samples for the study. | Posted | Mean | Standard Error | Ratio of mRNA copy numbers (TNF-α/5HKGs) | 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) |
|
|
|
| Secondary | 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. | IL-6 expression was measured in 7 (out of 11) participants in the Vitamin D group. For the placebo group, 6 of the 8 participants provided fat biopsy samples for the 2nd visit, and 4 participants provided for the 3rd visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. | Posted | Mean | Standard Error | Ratio of mRNA copy numbers (IL-6/5HKGs) | 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) |
|
|
|
| Secondary | 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. | iNOS expression was measured in 7 (out of 11) participants in the Vitamin D group. For the placebo group, 6 of the 8 participants provided fat biopsy samples for the 2nd visit, and 4 participants provided for the 3rd visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. | Posted | Mean | Standard Error | Ratio of mRNA copy numbers (iNOS/5HKGs) | 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) |
|
|
|
| Secondary | 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. | PAI-1 expression was measured in 7 (out of 11) participants in the Vitamin D group. For the placebo group, 6 of the 8 participants provided fat biopsy samples for the 2nd visit, and 4 participants provided for the 3rd visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. | Posted | Mean | Standard Error | Ratio of mRNA copy numbers (PAI-1/5HKGs) | 2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months) |
|
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|
| 0 |
| 11 |
| 1 |
| 11 |
| 1 |
| 11 |
| EG001 | Placebo | Participants in this group were assigned to receive weekly oral placebo drops (similar in taste and appearance to vitamin D) for six months. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| Percent change between baseline and 3rd visit |
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| TNF-α (3rd study visit) |
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| IL-6 (3rd study visit) |
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| iNOS (3rd study visit) |
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| PAI-1 (3rd study visit) |
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