HypoglycemiaNCT02687893
Effect of Hypoglycemia on Sleep
A study testing Aerobic Exercise and Resistance Exercise in people with Hypoglycemia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Aerobic Exercise and Resistance Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 18 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 45 years of age.
- Physically active on a regular basis, i.e. at least 3 days of physical activity per week.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
- Willingness to follow all study procedures, including attending all clinic visits.
- Willingness to sign informed consent and HIPAA documents.
Who cannot join
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
- Hematocrit of less than or equal to 34%.
- History of severe hypoglycemia during the past 12 months prior to screening visit or hypoglycemia unawareness as judged by the investigator.
Show all 26Show fewer
- Adrenal insufficiency.
- Any active infection.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs (except marijuana use).
- Seizure disorder.
- Active foot ulceration.
- Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
- Major surgical operation within 30 days prior to screening.
- Use of an investigational drug within 30 days prior to screening.
- Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
- Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
- Insulin resistance requiring more than 200 units per day.
- Need for uninterrupted treatment with acetaminophen.
- Current administration of oral or parenteral corticosteroids.
- Any life threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
- C peptide level of ≥0.5 ng/ml
- Any concurrent illness, other than diabetes, that is not controlled by a stable therapeutic regimen.
- Beta blockers or non-dihydropyridine calcium channel blockers.
- A positive response to any of the questions from the Physical Activity Readiness Questionnaire.
- Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
- Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the subject's safety or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: A Randomized, Three-way, Cross-over Study to Assess the Impact of Nocturnal Hypoglycemia on Sleep in Patients With Type 1 Diabetes
Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported, and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic hypoglycemia is a limitation of current intensive insulin therapies. Although severe hypoglycemia is associated with adverse events such as seizures and death, less severe nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response, leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle.
The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.
Read the detailed description
The study duration is 4 weeks long, during which subjects will undergo a 1 week run-in period followed by 3 randomized weeks of observational study. During the 1 week run-in period, subjects will familiarize themselves with the CGM and the other data collection procedures. Following the run-in week, the subject will be randomized to a specific order of observation weeks. The three observation weeks are a resistance training week, an aerobic exercise week and a control week with no explicit exercise. During the observation weeks, there will be 4 interventions planned, two during both the aerobic exercise and the resistance training week. See Schematic below for details. During both the aerobic exercise week intervention visits, subjects will exercise for ~45 minutes on a treadmill and during the resistance training week, subjects will perform strength training exercises for 1-3 sets per exercise at a weight that can be lifted for 8-12 repetitions (~60-80% of 1-repetition max). The duration of the resistance training period is expected to be ~45min. Subjects will continue to perform daily activities during each of the weeks.
During each week, the subject will wear one subcutaneous DexcomTM G4 or DexcomTM G4 Share continuous glucose monitoring (CGM) system, one activity monitor- ActiGraph wGT3X-BT or ActiGraph GT9X, one insulin pump (subject's own pump) and one Samsung Galaxy S4 phone loaded with two applications- meal memory and moves. The CGM system will provide sensed glucose data every 5 minutes. The CGM data will be blinded to the patient to prevent any abrupt changes in behavior. The accuracy of the sensed data will be obtained by reference measurements of capillary blood glucose. The activity monitor will be secured on the dominant wrist and uses an accelerometer to collect movement data at a high frequency (80Hz). The activity monitor measures both motion and ambient light, this data would be used to determine the various sleep quality measures. The subject's insulin dosage information from the pump will be downloaded for data analysis purposes. The subject's daily meal intake (photographic log and note diary) and daily movement pattern information will be downloaded from the phone. During the 4 exercise intervention visits, subject's heart rate, accelerometry information from the torso and oxygen consumption measured breath by breath may be collected for data analysis purposes.
- Conditions
- Hypoglycemia
- Being tested
- Aerobic Exercise, Resistance Exercise
- Keywords
- Sleep, Exercise
- Medical subject headings
- Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Subjects will exercise on a treadmill for 45 minutes twice during the intervention week. Subjects will exercise at a fixed intensity level to a target heart rate (±10%) based on the heart rate achieved at 60% of their VO2max determined at screening. The speed and grade of the treadmill will be adjusted by trained research personnel with a goal of keeping participants within their target heart rate range for the entire 45 minutes.
Resistance ExerciseBehavioural
Subjects will participate in resistance exercises for 45 minutes twice during the intervention week. Subjects will perform multiple-joint exercises with slow to moderate lifting velocity, for 1-3 sets per exercise at a weight that can be lifted for 8-12 repetitions (~60-80% of 1-repetition max). The exercises may include leg press, bench press, leg extension, leg flexion and seated row. Subjects will perform the exercises through the full range of motion. Between each set of repetitions, there would be a 2 minute rest period. The duration of the exercise testing would be approximately 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Week | Experimental | Subjects will complete 45 minutes of aerobic exercise twice during a 7 day period. Exercise will be graded based on the participant's relative capacity determined at the screening visit. Each exercise session will be followed by 60 minutes of monitored resting recovery. Receives: Behavioral: Aerobic Exercise |
| Resistance Exercise Week | Experimental | Subjects will complete 45 minutes of anaerobic exercise twice during a 7 day period. Each exercise session will be followed by 60 minutes of monitored resting recovery. Receives: Behavioral: Resistance Exercise |
| No Exercise Week | No intervention | Subjects will perform no exercise during this week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of time with sensed glucose less than 70 mg/dl post-exercise
The mean duration of time in hypoglycemia in minutes (defined as sensor glucose less than 70 mg/dl) will be calculated using sensor glucose data acquired by the Dexcom G4 for 16 hours after the beginning of exercise.
Measured: 16 hours
Secondary outcomes (21)
Mean duration with sensed glucose between 70 - 180 mg/dl post-exercise
The mean duration of time in euglycemia in minutes (defined as sensor glucose between 70-180 mg/dl) will be calculated using sensor glucose data acquired by the Dexcom G4 for 16 hours after the beginning of exercise.
Measured: 16 hours
Mean duration with capillary blood glucose between 70 - 180 mg/dl
The mean duration of time in euglycemia in minutes (defined as capillary blood glucose between 70-180 mg/dl) will be calculated using blood glucose data acquired by the Contour Next blood glucose (BG meter.
Measured: 4 weeks
Mean wake up after sleep onset duration post-exercise
Using data acquired from an Actigraph activity monitor, mean duration of time in minutes of wake after sleep onset for the 16 hours after the beginning of exercise.
Measured: 16 hours
Mean amplitude of glucose excursions
The mean amplitude of glucose excursions will be calculated using sensor glucose data acquired by the Dexcom G4.
Measured: 4 weeks
Mean duration of total sleep time
Using data acquired from an Actigraph activity monitor, mean duration of time in minutes that subject is asleep.
Measured: 4 weeks
Mean time subject in bed
Using data acquired from an Actigraph activity monitor, mean duration of time in minutes that subject is in bed.
Measured: 4 weeks
Mean time for sleep onset
Using data acquired from an Actigraph activity monitor, mean duration of time in minutes associated with the first epoch of the first 10 minute period of immobility starting from lights out time.
Measured: 4 weeks
Mean time of sleep efficiency
Using data acquired from an Actigraph activity monitor, a ratio of total sleep time to assumed sleep time multiplied by 100.
Measured: 4 weeks
Mean number of wake bouts
Using data acquired from an Actigraph activity monitor, mean of continuous blocks of length greater than or equal to 1 epoch in which each epoch is scored as wake in the assumed sleep period.
Measured: 4 weeks
Mean wake bout time
Using data acquired from an Actigraph activity monitor, mean time in minutes of wake after sleep onset divided by the number of wake bouts.
Measured: 4 weeks
Mean number of sleep bouts
Using data acquired from an Actigraph activity monitor, mean of continuous blocks of length greater than or equal to 1 epoch in which each epoch is scored as sleep in the assumed sleep period.
Measured: 4 weeks
Mean sleep bout time
Using data acquired from an Actigraph activity monitor, mean time in minutes of total sleep time divided by the number of sleep bouts.
Measured: 4 weeks
Mean number of carbohydrate treatments to treat hypoglycemia
Number of rescue carbohydrate treatments administered by the subject through study completion.
Measured: 4 weeks
Mean daily carbohydrate intake
Measuring the number of grams of carbohydrates consumed by the subjects through study completion.
Measured: 4 weeks
Mean daily insulin intake
Measuring the number of units of insulin administered to the subject by his/her insulin pump through study completion.
Measured: 4 weeks
Mean of total duration of activity by the subject
Using data acquired from an Actigraph activity monitor, mean duration of time in minutes of activity by the subject through study completion.
Measured: 4 weeks
Mean duration of time with sensed glucose < 50 mg/dl
The mean duration of time in hypoglycemia in minutes (defined as sensor glucose below 50 mg/dl) will be calculated using sensor glucose data acquired by the Dexcom G4.
Measured: 4 weeks
Mean duration of time with capillary blood glucose < 50 mg/dl
The mean duration of time in hypoglycemia in minutes (defined as capillary blood glucose below 50 mg/dl) will be calculated using capillary blood glucose data acquired by the Contour Next BG meter.
Measured: 4 weeks
Mean duration of time with capillary blood glucose < 70 mg/dl
The mean duration of time in hypoglycemia in minutes (defined as capillary blood glucose below 70 mg/dl) will be calculated using capillary blood glucose data acquired by the Contour Next BG meter.
Measured: 4 weeks
Mean duration of time with sensed glucose > 180 mg/dl
The mean duration of time in hyperglycemia in minutes (defined as sensor glucose greater than 180 mg/dl) will be calculated using sensor glucose data acquired by the Dexcom G4.
Measured: 4 weeks
Mean duration of time with capillary blood glucose > 180 mg/dl
The mean duration of time in hyperglycemia in minutes (defined as blood glucose greater than 180 mg/dl) will be calculated using glucose data acquired by the Contour Next BG meter.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter G. Jacobs, Oregon Health and Science University
- Investigators
- Peter G Jacobs, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687893
- Sponsor's protocol ID
- 15228
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Three-way, Cross-over Study to Assess the Impact of Nocturnal Hypoglycemia on Sleep in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02687893
- Acronym / sponsor ID
- 15228
- Conditions
- Hypoglycemia
- Keywords
- Sleep, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported, and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic hypoglycemia is a limitation of current intensive insulin therapies. Although severe hypoglycemia is associated with adverse events such as seizures and death, less severe nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response, leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle.
The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.
Detailed description
The study duration is 4 weeks long, during which subjects will undergo a 1 week run-in period followed by 3 randomized weeks of observational study. During the 1 week run-in period, subjects will familiarize themselves with the CGM and the other data collection procedures. Following the run-in week, the subject will be randomized to a specific order of observation weeks. The three observation weeks are a resistance training week, an aerobic exercise week and a control week with no explicit exercise. During the observation weeks, there will be 4 interventions planned, two during both the aerobic exercise and the resistance training week. See Schematic below for details. During both the aerobic exercise week intervention visits, subjects will exercise for ~45 minutes on a treadmill and during the resistance training week, subjects will perform strength training exercises for 1-3 sets per exercise at a weight that can be lifted for 8-12 repetitions (~60-80% of 1-repetition max). The duration of the resistance training period is expected to be ~45min. Subjects will continue to perform daily activities during each of the weeks.
During each week, the subject will wear one subcutaneous DexcomTM G4 or DexcomTM G4 Share continuous glucose monitoring (CGM) system, one activity monitor- ActiGraph wGT3X-BT or ActiGraph GT9X, one insulin pump (subject's own pump) and one Samsung Galaxy S4 phone loaded with two applications- meal memory and moves. The CGM system will provide sensed glucose data every 5 minutes. The CGM data will be blinded to the patient to prevent any abrupt changes in behavior. The accuracy of the sensed data will be obtained by reference measurements of capillary blood glucose. The activity monitor will be secured on the dominant wrist and uses an accelerometer to collect movement data at a high frequency (80Hz). The activity monitor measures both motion and ambient light, this data would be used to determine the various sleep quality measures. The subject's insulin dosage information from the pump will be downloaded for data analysis purposes. The subject's daily meal intake (photographic log and note diary) and daily movement pattern information will be downloaded from the phone. During the 4 exercise intervention visits, subject's heart rate, accelerometry information from the torso and oxygen consumption measured breath by breath may be collected for data analysis purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Week | Experimental | Behavioral: Aerobic ExerciseSubjects will complete 45 minutes of aerobic exercise twice during a 7 day period. Exercise will be graded based on the participant's relative capacity determined at the screening visit. Each exercise session will be followed by 60 minutes of monitored resting recovery. |
| Resistance Exercise Week | Experimental | Behavioral: Resistance ExerciseSubjects will complete 45 minutes of anaerobic exercise twice during a 7 day period. Each exercise session will be followed by 60 minutes of monitored resting recovery. |
| No Exercise Week | No intervention | –Subjects will perform no exercise during this week. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diagnosis of type 1 diabetes mellitus for at least 1 year.
- Male or female subjects 21 to 45 years of age.
- Physically active on a regular basis, i.e. at least 3 days of physical activity per week.
- Physically willing and able to perform 45 min of exercise (as determined by the investigator after reviewing the subjects activity level)
- Current use of an insulin pump.
Key exclusion criteria (26 listed)
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
- Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
- Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as report by the OHSU laboratory).
- Impaired liver function, defined as AST or ALT ≥2.5 times upper limit of normal, according to OHSU laboratory reference ranges.
- Hematocrit of less than or equal to 34%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseSubjects will exercise on a treadmill for 45 minutes twice during the intervention week. Subjects will exercise at a fixed intensity level to a target heart rate (±10%) based on the heart rate achieved at 60% of their VO2max determined at screening. The speed and grade of the treadmill will be adjusted by trained research personnel with a goal of keeping participants within their target heart rate range for the entire 45 minutes. | Behavioural | Aerobic Exercise Week |
| Resistance ExerciseSubjects will participate in resistance exercises for 45 minutes twice during the intervention week. Subjects will perform multiple-joint exercises with slow to moderate lifting velocity, for 1-3 sets per exercise at a weight that can be lifted for 8-12 repetitions (~60-80% of 1-repetition max). The exercises may include leg press, bench press, leg extension, leg flexion and seated row. Subjects will perform the exercises through the full range of motion. Between each set of repetitions, there would be a 2 minute rest period. The duration of the exercise testing would be approximately 45 minutes. | Behavioural | Resistance Exercise Week |
Primary outcome
Mean duration of time with sensed glucose less than 70 mg/dl post-exercise
Time frame: 16 hours
The mean duration of time in hypoglycemia in minutes (defined as sensor glucose less than 70 mg/dl) will be calculated using sensor glucose data acquired by the Dexcom G4 for 16 hours after the beginning of exercise.
21 secondary outcomes
Mean duration with sensed glucose between 70 - 180 mg/dl post-exercise
Time frame: 16 hours
Mean duration with capillary blood glucose between 70 - 180 mg/dl
Time frame: 4 weeks
Mean wake up after sleep onset duration post-exercise
Time frame: 16 hours
Mean amplitude of glucose excursions
Time frame: 4 weeks
Mean duration of total sleep time
Time frame: 4 weeks
Mean time subject in bed
Time frame: 4 weeks
Mean time for sleep onset
Time frame: 4 weeks
Mean time of sleep efficiency
Time frame: 4 weeks
Mean number of wake bouts
Time frame: 4 weeks
Mean wake bout time
Time frame: 4 weeks
Mean number of sleep bouts
Time frame: 4 weeks
Mean sleep bout time
Time frame: 4 weeks
Mean number of carbohydrate treatments to treat hypoglycemia
Time frame: 4 weeks
Mean daily carbohydrate intake
Time frame: 4 weeks
Mean daily insulin intake
Time frame: 4 weeks
Mean of total duration of activity by the subject
Time frame: 4 weeks
Mean duration of time with sensed glucose < 50 mg/dl
Time frame: 4 weeks
Mean duration of time with capillary blood glucose < 50 mg/dl
Time frame: 4 weeks
Mean duration of time with capillary blood glucose < 70 mg/dl
Time frame: 4 weeks
Mean duration of time with sensed glucose > 180 mg/dl
Time frame: 4 weeks
Mean duration of time with capillary blood glucose > 180 mg/dl
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter G Jacobs, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Resistance Exercise in people with Hypoglycemia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean duration of time with sensed glucose less than 70 mg/dl post-exercise (time frame: 16 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.