Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02804932|
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Dietary Supplement: Super Beets Other: Super Beets Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Nitrate Supplementation and Exercise Tolerance in Patients With Type 2 Diabetes|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Beetroot crystals (nitrate)
Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks.
Dietary Supplement: Super Beets
Nitrate rich beetroot powder (10g/day) for 8 weeks
Other Name: Beetroot crystals
Placebo Comparator: Placebo (beetroot powder, no nitrate)
Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks.
Other: Super Beets Placebo
Nitrate deficient beetroot powder (10g/day) for 8 weeks
Other Name: Beetroot crystals no nitrate
- Change in exercise capacity [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]A 12-lead ECG, symptom limited cardiopulmonary exercise testing with gas exchange measurements will be performed on a cycle ergometer using a ramp protocol to determine peak aerobic capacity (VO2peak) and exercise efficiency.
- Change in skeletal muscle perfusion during exercise [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]Forearm blood flow will be determined using Doppler ultrasound during rhythmic forearm exercise
- Change in skeletal muscle mitochondrial function [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]Muscle biopsies will be obtained from the vastus lateralis using a Bergstrom needle with suction under local anesthesia, which will yield ~200-250mg of tissue. Mitochondrial function will be assessed as follows: Fiber bundles will be chemically permeabilized with saponin and mitochondrial respiration will be analyzed by in situ high-resolution respirometry at 37°.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804932
|Contact: Darren P Casey, PhDemail@example.com|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Darren P Casey, PhD||University of Iowa|