A Study to Evaluate the Effect of Hyperoxia on Glucose Metabolism in Type 2 Diabetics
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-000341
Sponsor Protocol Number: 17-000341
About this study
The purpose of this study is to evaluate if breathing pure oxygen overnight affects insulin sensitivity in participants with diabetes.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- T2DM and
- On Metformin monotherapy and able to be washed off for 8 weeks
- HbA1c 6.5% -9.5%
- FPG ≥126 mg/dL (7.0 mmol/L) <270 mg/dl at screening
- 25 to 60 years of age
- BMI 22-37 kg/m²
Exclusion Criteria
- Diabetic meds other than metformin for 3months prior to study
- Hepatobiliary or renal disease
- Respiratory disease that may compromise the study in the opinion of the investigator
- Concurrent illness or chronic disease that in the opinion of the investigator may affect the outcome of the study
- Severe sleep apnea (sleep apnea will be analysed as a covariate)
- On antihypertensive medication
- Pregnant or lactating females
- Fasting triglycerides >500mg
- Nasal congestion/obstruction as determined by PI
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Adrian Vella, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available