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Trial record 43 of 2119 for:    digestive | Open Studies | United States

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 7, 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:
NCT02404870
First received: March 31, 2015
Last updated: January 24, 2017
Last verified: November 7, 2016
  Purpose

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.

Condition Intervention Phase
Diabetes
PTH
Vitamin D
Fibroblast Growth Factor (FGF23)
Phosphate
Drug: Placebo
Drug: Canagliflozin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Other
Official Title: Acute Effects of Canagliflozin, a Sodium Glucose Co-Transporter 2 (SGLT2) Inhibitor on Bone Metabolism in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • AUC of FGF23 [ Time Frame: First 24-72 hours ]

Secondary Outcome Measures:
  • FGF23 peack or AUC [ Time Frame: 12 hours ]
  • Transtubular reabsorption of phosphate [ Time Frame: Over 24 hrs x 5 days ]

Estimated Enrollment: 175
Study Start Date: September 10, 2014
Estimated Study Completion Date: May 1, 2019
Estimated Primary Completion Date: May 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Canagliflozin
Drug: Canagliflozin
Canagliflozin is a new oral drug for the treatment of type 2 diabetes mellitus (T2DM), and is one of two recently FDA approved sodium glucose co-transporter 2 (SGLT2) inhibitors, which target renal glucose reabsorption and offer promising improvement in HbA1C.
Placebo Comparator: 2
Placebo
Drug: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

We are targeting healthy 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02404870

Contacts
Contact: Kristina I Rother, M.D. (301) 435-4639 kristinar@intra.niddk.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Kristina I Rother, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02404870     History of Changes
Other Study ID Numbers: 140195  14-DK-0195 
Study First Received: March 31, 2015
Last Updated: January 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Diabetes
Phosphate
Fibroblast Growth Factor 23 (FGF23)
Vitamin D
PTH

Additional relevant MeSH terms:
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 24, 2017