Clinical trial NCT04427488: The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
Official title: The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Circadian Rhthym
Exercise
Type 2 Diabetes
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes is a metabolic disease characterized by partial insulin deficiency or insulin resistance in peripheral tissue. Type 2 diabetes, which has a very high prevalence worldwide, is a socially serious health problem. Exercise has beneficial effects on the glycemic profile, such as decreased glycemic hemoglobin (HbA1c) level, increased maximum oxygen consumption (VO2max) and improved insulin sensitivity in diabetes patients. When the literature is examined, it is seen that exercise is also effective in improving metabolic health. Although the metabolic benefits of exercise have been shown, there is no study of which type of exercise is more beneficial in what time of day in individuals with Type 2 diabetes. Circadian rhythm plays an important role in clarifying this issue because the circadian rhythm is impaired in the glucose metabolism of individuals with type 2 diabetes.The aim of this study is to investigate which exercise is more effective in which time period for individuals with Type 2 diabetes

Detailed description: INTRODUCTION: Type 2 diabetes is a metabolic disease characterized by partial insulin deficiency or insulin resistance in peripheral tissue. Type 2 diabetes, which has a very high prevalence worldwide, is a socially serious health problem. Complications seen with the disease negatively affect human health. Physical activity and regular exercise are shown in the first place with pharmacological treatment and diet approaches in the treatment of Type 2 diabetes. Exercise has beneficial effects on the glycemic profile, such as decreased glycemic hemoglobin (HbA1c) level, increased maximum oxygen consumption (VO2max) and improved insulin sensitivity in diabetes patients. When the literature is examined, it is seen that exercise is also effective in improving metabolic health. Although the metabolic benefits of exercise have been shown, there is no study of which type of exercise is more beneficial in what time of day in individuals with Type 2 diabetes. Circadian rhythm plays an important role in clarifying this issue because the circadian rhythm is impaired in the glucose metabolism of individuals with type 2 diabetes.

AIM: The aim of this study is to evaluate the effectiveness of structured exercises given in accordance with the circadian rhythm of individuals with type 2 diabetes.

METHOD: 30 people with Type 2 diabetes in accordance with the criteria for inclusion in the Department of Endocrine and Metabolism Diseases of Medipol University Hospital in Istanbul will be included in this study. Individuals who have been diagnosed with Type 2 diabetes between the ages of 35-65, who have body mass index between 25 and 30, who have HbA1c value\> 6.5%, who have fasting blood glucose\>126 mg/dl, who have Type 2 diabetes between 5-10 years, who have inactive physical activity, who independently can walk and volunteer to exercise for at least 3 days a week will be included in our study. Type 1 diabetes individuals, diagnosed with Latent Autoimmune Diabetes in Adults (LADA), having diabetic Ketoacidosis coma, orthopedic or surgical problems to prevent walking and exercising, foot ulcers, individuals have any neurologıcal problem and individuals with cardiac, pulmonary or systematic diseases that will cause contraindications will not be included in the study. Blood sample evaluations, circadian rhythm evaluation, 6-minute walking test, 30-second sit to stand test, quality of life assessment with Ferrans\&Powers Quality of Life Index of the individuals included will be carried out at the beginning of the study (T0) and at 6 (T1), 12 (T2) and 18 (T3) weeks after the study started Participants will be divided into two groups, morning (MC) and evening chronotypes (EC), according to their circadian rhythms. In both groups, there was a 6-week control period in which the participants continued to their routine treatment and did not perform any specific exercises. In the MC group, exercises were applied in the morning hours for the first 6 weeks and in the evening hours for the next 6 weeks. The EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks. A structured exercise program with aerobic and strengthening exercises was carried out in both groups for 3 days a week over 12 weeks. . Individuals were evaluated in terms of the blood test, functional capacity and quality of life at the baseline, 6 weeks before the exercise, 6 and 12 weeks after the exercises.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes
* Between the ages of 35-65
* Body mass index between 25 and 30
* HbA1c value\> 6.5%
* Fasting blood glucose\>126 mg/dl
* Inactive physical activity level
* Who independently can walk and volunteer to exercise for at least 3 days a week

Exclusion Criteria:

* Clinical diagnosis of Type 1 diabetes
* Clinical diagnosis of Latent Autoimmune Diabetes in Adults (LADA)
* Having diabetic Ketoacidosis coma
* Orthopedic or surgical problems to prevent walking and exercising
* Foot ulcers
* Neurologıcal, cardiac, pulmonary or systematic diseases

Primary outcomes:
measure: HbA1c evaluation
timeFrame: 3 hours
measure: Fasting glucose evaluation
timeFrame: 3 hours
measure: HDL (high density lipoprotein) evaluation
timeFrame: 3 hours
measure: LDL (low density lipoprotein) evaluation
timeFrame: 3 hours
measure: Total cholesterol evaluation
timeFrame: 3 hours
measure: Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire
timeFrame: 10 minutes
Secondary outcomes:
measure: 6-minute walking test
timeFrame: 10 minutes
measure: 30-second sit to stand test
timeFrame: 10 minutes
measure: Ferrans&Powers Quality of Life
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
citation: Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.
citation: Menek MY, Budak M. Effect of exercises according to the circadian rhythm in type 2 diabetes: Parallel-group, single-blind, crossover study. Nutr Metab Cardiovasc Dis. 2022 Jul;32(7):1742-1752. doi: 10.1016/j.numecd.2022.04.017. Epub 2022 Apr 29.