Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05231031 |
| Other study ID # |
DM and Cortisol |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
August 15, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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) .
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.
