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Protocol Details

Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

14-DK-0195

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Diabetes;
Phosphate;
Fibroblast Growth Factor 23 (FGF23);
Vitamin D;
PTH

Recruitment Keyword(s)

None

Condition(s)

Healthy Volunteers

Investigational Drug(s)

Canagliflozin

Investigational Device(s)

None

Intervention(s)

Drug: Placebo
Drug: Canagliflozin

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

- Canagliflozin (sold as InvokanaTM) is a new medicine for diabetes. But it might increase the bone fracture risk in people with diabetes.

Objective:

- To see if Invokana has negative side effects on bone health.

Eligibility:

- Healthy men ages 18 45.

Design:

- Participants will be screened with a medical history, physical exam, and blood tests. A nutritionist will discuss their dietary history and the study dietary requirements. Participants will get a food diary to record what they eat and drink on 3 separate days.

- Participants will have a DEXA scan x-ray test of bone health. Participants will lie still on a table while a small camera passes over the body.

- Participants will have 2 stays in the clinic. They will be 1 week apart and each last 6 overnights starting on a Sunday.

- Before each stay, participants will:

- Pick up food each day for 7 days. They will get breakfast, lunch, dinner, and snacks. They must eat only the food provided during these times.

- Collect their urine twice.

- During the stays, participants will:

- Be evaluated by a doctor and have blood drawn.

- On each Monday, participants will:

- Skip breakfast

- At about 8 a.m. take a placebo pill in one stay, the study drug in the other stay.

- Drink 6 ounces of water every 2 hours for 4 hours.

- An intravenous (IV) catheter will be inserted into an arm. Blood will be drawn every 2 hours from 8 a.m. until noon.

- Get lunch.

- Have blood testing again at 8pm and midnight.

- Repeat the testing days 2 5.

- Have urine collected.

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Eligibility

INCLUSION CRITERIA:

We are targeting healthy men and women greater than or equal to 18 years old, inclusive of all races and ethnicity within a BMI of 20 30 kg/m(2). Specifically, we have defined healthy to mean: normal fasting glucose and hemoglobin A1c less than or equal to 6%, normal Hb, no glucosuria, normal renal function (based on normal serum creatinine + Cystatin C), urine albumin:creatinine ratio, protein:creatinine ratio, and GFR > 80 as calculated by the CKD-Epi equation and normal lab urinalysis.

EXCLUSION CRITERIA:

If you have any of the following health issues, you cannot participate in the study:

-Presence of heart disease, untreated high blood pressure (>140/90 mm Hg), orthostatic hypotension or symptomatic hypotension, cancer, diabetes, recurrent symptomatic hypoglycemia and /or history of recurrent genital or urinary tract infection, thyroid disease, or any other condition that affects bone health

-Past history of eating disorder or psychiatric disorders, including severe depression, anxiety, or psychosis or presently on treatment with medications for any of these conditions

-Taking certain medications, especially those that affect bone metabolism (e.g., high dose vitamin D [>1000 units daily] or calcium supplements [>800mg daily], high dose vitamin A [>20,000 units daily], phosphate binding antacids, calcitonin, calcitriol, growth hormone, or any anti-seizure medications for any reason including valproic acid, lamotrigine), certain medications for high blood pressure (diuretics), steroids including inhalers, diet/weight loss medications, or any other medications at the discretion of the principal investigator and/or study team

-Have started, increased or decreased calcium [>400mg daily] or vitamin D [>1000 units daily] supplements within 2 weeks of the study

-Dependence or regular use of alcohol (>2 drinks per day), tobacco (smoking or chewing), amphetamines, cocaine, heroin or marijuana over the past 6 months

-Volunteers will be excluded if they have abnormal blood concentrations of

--inorganic phosphate level (less than or equal to 2.5 mg/dl or greater than or equal to 4.8 mg/dl),

--parathyroid hormone (PTH) (less than or equal to 60 pg/ml),

--creatinine (less than or equal to 1.5 mg/dl) or eGFR (< 80 ml/min/1.73sq.m),

--fasting glucose (greater than or equal to 100 mg/dl),

--hemoglobin (less than or equal to 11 g/dl),

--liver function tests (more than twice normal),

--testosterone (less than or equal to 260 ng/dl)

-Participation in a vigorous exercise program (>3h/day of vigorous activity)

-Consume more than 300 mg/day of caffeine (about two to three 8 fluid ounce servings)

-Have strict dietary concerns (e.g., vegan or kosher diet, multiple food allergies)

-Cannot commit to the research experience at the Clinical Research Center as required by the study timeline

-Have previous hypersensitivity reaction to canagliflozin (including but not limited to rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing).

- Positive urine pregnancy test and/or planning to become pregnant during the course of the study.

- You are unwilling to use effective contraceptive methods for duration of study (hormonal or barrier.

- Irregular menstrual cycles


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Michael T. Collins, M.D.
National Institute of Dental And Craniofacial Research (NIDCR)
BG 30 RM 228
30 CONVENT DR
BETHESDA MD 20814
(301) 496-4913
mc247k@nih.gov

Michael T. Collins, M.D.
National Institute of Dental And Craniofacial Research (NIDCR)
BG 30 RM 228
30 CONVENT DR
BETHESDA MD 20814
(301) 496-4913
mc247k@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02404870

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