Diabetes MellitusNCT05231031
Effect of Breathing and Relaxation Exercises on Serum Cortisol Levels in Type 2 Diabetic Patients
A study testing Aerobic exercise, breathing exercise and Relaxation training in people with Diabetes Mellitus and Stress, run by Cairo University at 1 site in Egypt.
Trial summary
Background: Diabetes is a fast-growing health problem in Egypt with a significant impact on morbidity, mortality, and health care resources. Aim of the study: To assess the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Stress
- What is being tested?
- Aerobic exercise, breathing exercise and Relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 15 Aug 2021
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Sixty diabetic patients (29 women and 31 men), their age between 45 and 65 years .
- They had type 2 diabetes mellitus for more than 5years.
- Their HbA1c value from 6.5% to 7.5%.
- Stress scores on the Perceived stress scale are >13 in the eligibility check assessment.
- All patients are under full medical supervision.
- Their physical activity level is less than 30 minutes of aerobic training in the week.
- Their body mass index ranged from 25 to 34.9. (overweight and obesity class I).
Who cannot join
- • Any patient is known to have an unstable medical condition and sleeping disorder.
- Indication of receiving treatments for depression and anxiety.
- Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
- Cushing's disease (hypercortisolism) or Addison's disease (hypocortisolism).
- Hepatic diseases and dyslipidemia.
- Patients with renal and vascular diseases.
- Severe hypertensive patients (higher than 200/120 mmHg).
- Any acute or chronic inflammatory disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Diabetes is a fast-growing health problem in Egypt with a significant impact on morbidity, mortality, and health care resources. Aim of the study: To assess the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients. Subject and Methods: sixty, type 2 diabetic patients for more than 5 years were selected from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. Their age ranged from 40 to 50 years. Serum cortisol and blood glucose tests were done before the start of the study and after 6 weeks. The patients were randomly assigned into two equal groups in number (30 patients for each group) performed 3 sessions/week for 6 weeks. Group A received aerobic exercise in the form of walking on a treadmill, breathing exercise, and mindfulness meditation, and group B received continuous aerobic exercise only in the form of walking on a treadmill. ( The exercise program included 45 minutes and consist of warming up phase of slow walking on the treadmill for 5 minutes, training phase 35 minutes, and cooling down for 5 minutes) .
Read the detailed description
Diabetes is a metabolic disorder that requires ongoing medical care through multi-factor risk reduction strategies in addition to blood sugar control. Continuing education and support for diabetes self-management are essential to prevent acute complications and reduce the risk of long-term complications. There is a lot of evidence supporting a number of interventions to improve diabetes outcomes.
Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia. This may be due to insufficient insulin secretion, resistance to the peripheral effects of insulin, or both. The synergistic effect of chronic hyperglycemia and other metabolic abnormalities in diabetic patients can cause damage to various organ systems, leading to disabling and life-threatening health complications.
The global prevalence of type 2 diabetes has increased from 8.3% in 2013 to 9.3% in 2019. This increase has been higher in lower- to middle-income countries compared to high-income ones. Diabetes treatment includes behavioral and pharmacological approaches. Globally, it is estimated that only 23% (30% in Latin America) of people with diabetes have reached the set target. However, it is a challenge for treating physicians to choose a treatment that is tailored to each patient.
Egypt is the ninth-largest country in terms of type 2 diabetes mellitus (T2DM) patients, according to the International Diabetes Federation (IDF). T2DM patients have increased threefold in the last 20 years, with a current prevalence of 15.6 percent among people aged 20 to 79.
T2DM is a metabolic disorder that has both microvascular and macrovascular consequences. Controlling blood glucose levels is linked to a lower risk of microvascular consequences (retinopathy, nephropathy, and neuropathy) as well as macrovascular issues (lower incidence of heart attacks, strokes, and better blood flow to the legs).
The World Health Organisation (WHO) defines diabetes as a "metabolic disorder of multiple etiology characterized by chronic hyperglycemia with disturbance of carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both. " The most prevalent form of diabetes is type 2, as an estimated 90% of diabetes patients are diagnosed with this form, and the majority of the remaining 10% of patients have type 1 diabetes (T1D), although there are other rare types. There is a range of effective treatments that reduce hyperglycemia in T2D patients, which mediate their effects by improving insulin secretion or decreasing peripheral tissue insulin resistance.
Diabetes is a chronic metabolic disease that can negatively affect the quality of life. Psychological stress and negative emotions have a two-way effect on diabetes control. Stress increases the risk and severity of diabetes by stimulating the hypothalamus-pituitary-adrenal gland (HPA) and sympathetic nerve axis and parasympathetic nerve withdrawal, leading to cortisol, epinephrine, norepinephrine, growth hormone, glucagon, catecholamines, Prolactin, leptin, and neuropeptide Y. Chronic activation of the HPA axis is related to poor control of complications such as diabetes and diabetic neuropathy. Elevated levels of inflammatory cytokines lead to insulin resistance in patients with type 2 diabetes. Chronic psychological stress can lead to an increased risk of insulin resistance, high blood pressure, and cardiovascular events.
Psychological stress has been linked to the development of type 2 diabetes. Meditation exercise can be viewed as a combination of mindfulness intervention and physical activity. This may partly explain why meditation exercises have a more positive effect on type 2 diabetes than other active and non-exercise exercises. A large number of studies have shown that meditation exercise is effective for blood sugar control in patients with type 2 diabetes.
Meditation interventions were shown to have a significant effect on changing cortisol levels assessed from blood samples.
Mindfulness meditation-based strategies are simple, easy to grasp and practice, and do not incur an additional cost. Meditation-based therapies may offer immediate positive benefits in such individuals.
Deep breathing has been shown to have a positive impact on various factors like stress, anxiety, and negative affect in numerous studies.
Breathing exercises, also known as "diaphragmatic breathing" or "deep breathing", are defined as effective comprehensive training of the body and mind to deal with stress and physical and mental conditions. Diaphragm breathing involves the contraction of the diaphragm, the expansion of the abdomen, and the deepening of inhalation and exhalation, thereby reducing the respiratory rate and maximizing the amount of gas in the blood. The benefits of diaphragmatic breathing have been studied in conjunction with meditation.
Physical activity is a broad term that applies to any physical movement or activity that requires energy consumption by skeletal muscles. Aerobic exercise is a specific subcategory of physical activity. It is characterized by the rhythmic and continuous exercise of a large number of muscles, which mainly relies on the energy production process produced by oxygen metabolism. The main goal of aerobic exercise is to improve or maintain cardiorespiratory fitness, that is, the ability of the circulatory system and respiratory system to supply oxygen during continuous exercise
Exercise as a regular physical activity is found to be an efficient influencer that would switch back most of the known type 2 diabetes mellitus factors toward healthier positions. Exercise is proven to have clinical benefits, such as improved insulin sensitivity, reductions in glycosylated hemoglobin (A1C), and increased peak oxygen consumption (VO2peak) which are definitely preventive toward diabetes. Exercise improves blood glucose control in type 2 diabetes, reduces cardiovascular risk factors, and regulates body weight by reducing body fat percentage and enhancing lean mass.
Aerobic exercise consists of continuous, rhythmic movement of large muscle groups, such as in walking, jogging, and cycling. The most recent ADA guidelines state that individual sessions of aerobic activity should ideally last at least 30 minutes per day and be performed 3 to 7 days of the week. Moderate to vigorous (65%-90% of maximum heart and rate) aerobic exercise training improves VO2max cardiac output, which is associated with substantially reduced cardiovascular and overall mortality risk in patients with type 2 diabetes.
According to a study published in "Psycho-neuroendocrinology", there is a clear link between the stress hormone cortisol and high blood sugar levels in patients with type 2 diabetes mellitus (T2DM) The researchers explained that in healthy people, cortisol naturally fluctuates throughout the day. This natural fluctuation usually peaks in the morning and falls at night. However, patients with type 2 diabetes have lower levels of cortisol during the day and higher levels of glucose higher serum cortisol levels are a risk factor for future incidence of diabetes.
Cortisol is a glucocorticoid produced by activating the hypothalamic-pituitary-adrenal axis. It is called the "stress hormone" because it plays a major role in the body's response to stress. The activation of the HPA axis and the increase in cortisol secretion are important and adaptive parts of the human stress response, which can promote survival. However, when the stressor is activated for a long time, the HPA axis will become dysregulated, causing abnormal cortisol secretion and negatively affecting the body. Cortisol inhibits inflammation and allergic reactions, has an immunosuppressive effect, and also affects metabolic processes through gluconeogenesis (the release of amino acids from proteins in skeletal muscle and bone), glycogenolysis, and lipolysis
This study was conducted to investigate the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients.
- Conditions
- Diabetes Mellitus, Stress
- Being tested
- Aerobic exercise, breathing exercise, Relaxation training
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
continuous aerobic exercise on a treadmill
breathing exerciseBehavioural
continuous aerobic exercise plus breathing exercise (Mindfulness)
Relaxation trainingBehavioural
continuous aerobic exercise plus relaxation training
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Active comparator | This group received continuous aerobic exercise only in the form of walking on a treadmill 3 sessions/week for 6 weeks Receives: Behavioral: Aerobic exercise |
| Aerobic, Breathing exercises , and relaxation training | Experimental | This group received continuous aerobic exercise only in the form of walking on a treadmill 3 sessions/week for 6 weeks in addition to breathing exercises and relaxation training for the same period Receives: Behavioral: Aerobic exercise; Behavioral: breathing exercise; Behavioral: Relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fating blood glucose
blood sampling for blood glucose after 9 hours fasting
Measured: 6 weeks
Serum cortisol level
blood sampling for cortisol at 8 am
Measured: 6 weeks
Secondary outcomes (1)
The perceived stress score (PSS)
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2021
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hady Atef Labib, Cairo University
- Investigators
- Hady Atef, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231031
- Sponsor's protocol ID
- DM and Cortisol
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2022
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval can be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing and Relaxation Exercises on Serum Cortisol Levels in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05231031
- Acronym / sponsor ID
- DM and Cortisol
- Conditions
- Diabetes Mellitus, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 9 Feb 2022 (actual)
- 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.
Background: Diabetes is a fast-growing health problem in Egypt with a significant impact on morbidity, mortality, and health care resources. Aim of the study: To assess the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients. Subject and Methods: sixty, type 2 diabetic patients for more than 5 years were selected from the outpatient clinic of the Faculty of Physical Therapy, Cairo University. Their age ranged from 40 to 50 years. Serum cortisol and blood glucose tests were done before the start of the study and after 6 weeks. The patients were randomly assigned into two equal groups in number (30 patients for each group) performed 3 sessions/week for 6 weeks. Group A received aerobic exercise in the form of walking on a treadmill, breathing exercise, and mindfulness meditation, and group B received continuous aerobic exercise only in the form of walking on a treadmill. ( The exercise program included 45 minutes and consist of warming up phase of slow walking on the treadmill for 5 minutes, training phase 35 minutes, and cooling down for 5 minutes) .
Detailed description
Diabetes is a metabolic disorder that requires ongoing medical care through multi-factor risk reduction strategies in addition to blood sugar control. Continuing education and support for diabetes self-management are essential to prevent acute complications and reduce the risk of long-term complications. There is a lot of evidence supporting a number of interventions to improve diabetes outcomes.
Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia. This may be due to insufficient insulin secretion, resistance to the peripheral effects of insulin, or both. The synergistic effect of chronic hyperglycemia and other metabolic abnormalities in diabetic patients can cause damage to various organ systems, leading to disabling and life-threatening health complications.
The global prevalence of type 2 diabetes has increased from 8.3% in 2013 to 9.3% in 2019. This increase has been higher in lower- to middle-income countries compared to high-income ones. Diabetes treatment includes behavioral and pharmacological approaches. Globally, it is estimated that only 23% (30% in Latin America) of people with diabetes have reached the set target. However, it is a challenge for treating physicians to choose a treatment that is tailored to each patient.
Egypt is the ninth-largest country in terms of type 2 diabetes mellitus (T2DM) patients, according to the International Diabetes Federation (IDF). T2DM patients have increased threefold in the last 20 years, with a current prevalence of 15.6 percent among people aged 20 to 79.
T2DM is a metabolic disorder that has both microvascular and macrovascular consequences. Controlling blood glucose levels is linked to a lower risk of microvascular consequences (retinopathy, nephropathy, and neuropathy) as well as macrovascular issues (lower incidence of heart attacks, strokes, and better blood flow to the legs).
The World Health Organisation (WHO) defines diabetes as a "metabolic disorder of multiple etiology characterized by chronic hyperglycemia with disturbance of carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both. " The most prevalent form of diabetes is type 2, as an estimated 90% of diabetes patients are diagnosed with this form, and the majority of the remaining 10% of patients have type 1 diabetes (T1D), although there are other rare types. There is a range of effective treatments that reduce hyperglycemia in T2D patients, which mediate their effects by improving insulin secretion or decreasing peripheral tissue insulin resistance.
Diabetes is a chronic metabolic disease that can negatively affect the quality of life. Psychological stress and negative emotions have a two-way effect on diabetes control. Stress increases the risk and severity of diabetes by stimulating the hypothalamus-pituitary-adrenal gland (HPA) and sympathetic nerve axis and parasympathetic nerve withdrawal, leading to cortisol, epinephrine, norepinephrine, growth hormone, glucagon, catecholamines, Prolactin, leptin, and neuropeptide Y. Chronic activation of the HPA axis is related to poor control of complications such as diabetes and diabetic neuropathy. Elevated levels of inflammatory cytokines lead to insulin resistance in patients with type 2 diabetes. Chronic psychological stress can lead to an increased risk of insulin resistance, high blood pressure, and cardiovascular events.
Psychological stress has been linked to the development of type 2 diabetes. Meditation exercise can be viewed as a combination of mindfulness intervention and physical activity. This may partly explain why meditation exercises have a more positive effect on type 2 diabetes than other active and non-exercise exercises. A large number of studies have shown that meditation exercise is effective for blood sugar control in patients with type 2 diabetes.
Meditation interventions were shown to have a significant effect on changing cortisol levels assessed from blood samples.
Mindfulness meditation-based strategies are simple, easy to grasp and practice, and do not incur an additional cost. Meditation-based therapies may offer immediate positive benefits in such individuals.
Deep breathing has been shown to have a positive impact on various factors like stress, anxiety, and negative affect in numerous studies.
Breathing exercises, also known as "diaphragmatic breathing" or "deep breathing", are defined as effective comprehensive training of the body and mind to deal with stress and physical and mental conditions. Diaphragm breathing involves the contraction of the diaphragm, the expansion of the abdomen, and the deepening of inhalation and exhalation, thereby reducing the respiratory rate and maximizing the amount of gas in the blood. The benefits of diaphragmatic breathing have been studied in conjunction with meditation.
Physical activity is a broad term that applies to any physical movement or activity that requires energy consumption by skeletal muscles. Aerobic exercise is a specific subcategory of physical activity. It is characterized by the rhythmic and continuous exercise of a large number of muscles, which mainly relies on the energy production process produced by oxygen metabolism. The main goal of aerobic exercise is to improve or maintain cardiorespiratory fitness, that is, the ability of the circulatory system and respiratory system to supply oxygen during continuous exercise
Exercise as a regular physical activity is found to be an efficient influencer that would switch back most of the known type 2 diabetes mellitus factors toward healthier positions. Exercise is proven to have clinical benefits, such as improved insulin sensitivity, reductions in glycosylated hemoglobin (A1C), and increased peak oxygen consumption (VO2peak) which are definitely preventive toward diabetes. Exercise improves blood glucose control in type 2 diabetes, reduces cardiovascular risk factors, and regulates body weight by reducing body fat percentage and enhancing lean mass.
Aerobic exercise consists of continuous, rhythmic movement of large muscle groups, such as in walking, jogging, and cycling. The most recent ADA guidelines state that individual sessions of aerobic activity should ideally last at least 30 minutes per day and be performed 3 to 7 days of the week. Moderate to vigorous (65%-90% of maximum heart and rate) aerobic exercise training improves VO2max cardiac output, which is associated with substantially reduced cardiovascular and overall mortality risk in patients with type 2 diabetes.
According to a study published in "Psycho-neuroendocrinology", there is a clear link between the stress hormone cortisol and high blood sugar levels in patients with type 2 diabetes mellitus (T2DM) The researchers explained that in healthy people, cortisol naturally fluctuates throughout the day. This natural fluctuation usually peaks in the morning and falls at night. However, patients with type 2 diabetes have lower levels of cortisol during the day and higher levels of glucose higher serum cortisol levels are a risk factor for future incidence of diabetes.
Cortisol is a glucocorticoid produced by activating the hypothalamic-pituitary-adrenal axis. It is called the "stress hormone" because it plays a major role in the body's response to stress. The activation of the HPA axis and the increase in cortisol secretion are important and adaptive parts of the human stress response, which can promote survival. However, when the stressor is activated for a long time, the HPA axis will become dysregulated, causing abnormal cortisol secretion and negatively affecting the body. Cortisol inhibits inflammation and allergic reactions, has an immunosuppressive effect, and also affects metabolic processes through gluconeogenesis (the release of amino acids from proteins in skeletal muscle and bone), glycogenolysis, and lipolysis
This study was conducted to investigate the effect of breathing and relaxation exercises on serum cortisol levels in type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Active comparator | Behavioral: Aerobic exerciseThis group received continuous aerobic exercise only in the form of walking on a treadmill 3 sessions/week for 6 weeks |
| Aerobic, Breathing exercises , and relaxation training | Experimental | Behavioral: Aerobic exercise, Behavioral: breathing exercise, Behavioral: Relaxation trainingThis group received continuous aerobic exercise only in the form of walking on a treadmill 3 sessions/week for 6 weeks in addition to breathing exercises and relaxation training for the same period |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Sixty diabetic patients (29 women and 31 men), their age between 45 and 65 years .
Key exclusion criteria (8 listed)
- • Any patient is known to have an unstable medical condition and sleeping disorder.
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 exercisecontinuous aerobic exercise on a treadmill | Behavioural | Aerobic exercise, Aerobic, Breathing exercises , and relaxation training |
| breathing exercisecontinuous aerobic exercise plus breathing exercise (Mindfulness) | Behavioural | Aerobic, Breathing exercises , and relaxation training |
| Relaxation trainingcontinuous aerobic exercise plus relaxation training | Behavioural | Aerobic, Breathing exercises , and relaxation training |
Primary outcome
Fating blood glucose
Time frame: 6 weeks
blood sampling for blood glucose after 9 hours fasting
Serum cortisol level
Time frame: 6 weeks
blood sampling for cortisol at 8 am
1 secondary outcome
The perceived stress score (PSS)
Time frame: 6 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 9 Feb 2022.
- Individual participant dataSharing planned: Yes. After approval can be shared
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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.
Hady Atef, PhD principal investigator
Cairo 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, breathing exercise and Relaxation training in people with Diabetes Mellitus and Stress, run by Cairo University at 1 site in Egypt.
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 8 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 9 Feb 2022. 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 Egypt. 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?
Fating blood glucose (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 9 Feb 2022.