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The PI was leaving Pennington
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This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension) or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D. This may reduce the chances of developing diabetes or high blood pressure or both later in life.
Study visits will measure temperature, fasting glucose, resting blood pressure, respiratory rate, height, weight and waist circumference. A brief medical History will be taken, followed by an abbreviated physical exam. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will be completed.
Based on your fasting glucose and/or resting blood pressure you will be in one of the three arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and prehypertension (arm 3). After determining the arm of the study you are in, you will be randomly assigned to receive either a placebo or vitamin D supplementation.
If you are in the first arm with prediabetes (fasting glucose 100-125 mg/dL), the primary outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in the second arm with prehypertension (resting blood pressure 120-139/80-89 mm Hg), the primary outcome measure will change in resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. If you are in third arm with prediabetes and prehypertension, both these measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up to 5 years. A repeat blood test to check vitamin D levels will be done at 8 and 16 weeks (and periodically as necessary) during the study.
Other measures will be taken as are routine in your doctor's office.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting glucose (blood sugar) | Experimental | This group is associated with a diagnosis of prediabetes |
|
| Resting Blood pressure | Experimental | This group is associated with a diagnosis of prehypertension. |
|
| Fasting Glucose & Resting Blood Pressure | Experimental | coexisting prediabetes and prehypertension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D supplementation | Other | Vitamin D |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention | An analysis of the fasting glucose, resting blood pressure and/or both will be performed. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will also be done. At the end of 8 weeks fasting blood glucose and resting blood pressure will be measured. If the desired results (fasting glucose less than 100 mg/dL and/or resting blood pressure less than 120/80 mm Hg) are not seen these measures will be repeated at 16 weeks. You will be asked to stay in the study for up to 5 years. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alok Gupta, MD, AAFP, FASH | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Care Center | Baton Rouge | Louisiana | 70806 | United States | ||
| Bradley L. Meek, MD, Internal Medicine at Hennessy |
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|
| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Metabolic Clinic Women's Hospital | Baton Rouge | Louisiana | 70809 | United States |
| Egan Wellness Clinic/AntiAging & Skin Care Spa | Covington | Louisiana | 70433 | United States |
| Amarica Family Practice Office (Second Location) | Durham | North Carolina | 27704 | United States |
| Amarica Family Practice Office (First Location) | Roxboro | North Carolina | 27573 | United States |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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