Vitamin D and Type 2 Diabetes Study



Status:Active, not recruiting
Conditions:Endocrine, Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - Any
Updated:1/13/2019
Start Date:October 2013
End Date:May 2021

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The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D
supplementation works to delay the onset of type 2 diabetes in people at risk for the disease
and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D
supplementation works to delay the onset of type 2 diabetes in people at risk for the disease
and to gain a better understand how vitamin D affects glucose (sugar) metabolism. Researchers
at US sites will enroll people with pre-diabetes (people who have higher than normal blood
glucose level but not high enough to meet the diagnosis of diabetes). The study will enroll
participants over approximately 2 years and participants will be followed for approximately 3
years. Participants will receive either Vitamin D or a placebo by chance. Participants will
take 1 pill a day for the duration of the study.

Inclusion Criteria:

1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the
following glycemic criteria at the baseline visit:

1. Fasting plasma glucose (FPG) 100-125 mg/dL

2. 2-hour plasma glucose (2hPG) 140-199 mg/dL

3. Hemoglobin A1c (HbA1c) 5.7-6.4%

2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska
Native, Native Hawaiian or Other Pacific Islander).

3. Body Mass Index 22.5 to 42 kg/m2

4. Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria:

1. Diabetes based on either of the following criteria:

1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable
medication approved by the FDA for type 2 diabetes), used for any condition (e.g.
pre-diabetes, diabetes, polycystic ovarian syndrome.

2. Meeting the diagnosis criteria for diabetes

2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.

3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to
become pregnant in the next 4 years or unprotected intercourse. History of gestational
diabetes is not an exclusion criterion.

4. Currently breastfeeding.
We found this trial at
25
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: John Foreyt, PhD
Phone: 713-798-3741
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Anastassios G Pittas, MD, MS
Phone: 617-636-2842
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Sangeeta Kashyap, MD
Phone: 216-444-3955
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Ranee Chatterjee Montgomery, MD, MPH
Phone: 919-688-7863
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Anne Peters, MD
Phone: 323-361-8416
University of Southern California The University of Southern California is one of the world’s leading...
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305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Principal Investigator: Emilia Lao, MD
Phone: 212-420-3450
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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New York, NY
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Neda Rasouli, MD
Phone: 720-848-7710
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Daniel Hsia, MD
Phone: 225-763-3000
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Patrick O'Neil, PhD
Phone: 843-792-5427
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Lisa Neff, MD, MS
Phone: 312-503-3413
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Philip Raskin, MD
Phone: 214-342-2383
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Decatur, Georgia 30033
Principal Investigator: Lawrence Phillips, MD
Phone: 404-235-3024
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Hyattsville, Maryland 20782
Principal Investigator: Vanita Aroda, MD
Phone: 301-560-2948
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: David C Robbins, MD
Phone: 913-588-6052
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Memphis, Tennessee 38163
Principal Investigator: Karen C Johnson, MD, MPH
Phone: 901-448-8400
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Minneapolis, Minnesota 55454
Principal Investigator: Chhavi Chadha, MD
Phone: 612-341-1950
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New Orleans, Louisiana 70112
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Omaha, Nebraska 68105
Principal Investigator: Cyrus Desouza, MBBS
Phone: 402-995-3924
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Cyrus V Desouza, MBBS
Phone: 402-559-6279
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Orlando, Florida 32804
Principal Investigator: Richard E Pratley, MD
Phone: 407-303-7193
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Orlando, Florida 32803
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Palo Alto, California 94304
Principal Investigator: Sun H Kim, MD, MS
Phone: 650-485-3910
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Phoenix, Arizona 85016
Principal Investigator: Jennifer Weil, MD
Phone: 602-640-2190
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Portland, Oregon 97227
Principal Investigator: Erin LeBlanc, MD, MPH
Phone: 503-335-6380
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Scarborough, Maine 04074
Principal Investigator: Irwin Brodsky, Md, MPH
Phone: 207-661-7624
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