The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes (Circadian)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Morning Chronotype group
Evening Chronotype group
Sponsored by

About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Circadian Rhthym, Exercise, Type 2 Diabetes
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
Sites / Locations
- Istanbul Medipol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Morning Chronotype (MC) Group
Evening Chronotype (EC) Group
Arm Description
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
Outcomes
Primary Outcome Measures
HbA1c evaluation
Blood sample scores are changeable
Fasting glucose evaluation
Blood sample are changeable
HDL (high density lipoprotein) evaluation
Blood sample are changeable
LDL (low density lipoprotein) evaluation
Blood sample are changeable
Total cholesterol evaluation
Blood sample are changeable
Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire
Scores can range from 16-86. Scores of 41 and below indicate "evening types". Scores of 59 and above indicate "morning types". Scores between 42 and 58 indicate "intermediate types" in Morningness Eveningness Questionnaire
Secondary Outcome Measures
6-minute walking test
An increase in the distance walked indicates improvement in basic mobility.
30-second sit to stand test
The wide variety of ability levels indicates with high scores
Ferrans&Powers Quality of Life
High scores indicates high Quality of life in individuals with diabetes
Full Information
NCT ID
NCT04427488
First Posted
June 8, 2020
Last Updated
December 30, 2021
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04427488
Brief Title
The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
Acronym
Circadian
Official Title
The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Circadian Rhthym, Exercise, Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morning Chronotype (MC) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Evening Chronotype (EC) Group
Arm Type
Experimental
Arm Description
The EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks
Intervention Type
Other
Intervention Name(s)
Morning Chronotype group
Intervention Description
Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
Intervention Type
Other
Intervention Name(s)
Evening Chronotype group
Intervention Description
Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
Primary Outcome Measure Information:
Title
HbA1c evaluation
Description
Blood sample scores are changeable
Time Frame
3 hours
Title
Fasting glucose evaluation
Description
Blood sample are changeable
Time Frame
3 hours
Title
HDL (high density lipoprotein) evaluation
Description
Blood sample are changeable
Time Frame
3 hours
Title
LDL (low density lipoprotein) evaluation
Description
Blood sample are changeable
Time Frame
3 hours
Title
Total cholesterol evaluation
Description
Blood sample are changeable
Time Frame
3 hours
Title
Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire
Description
Scores can range from 16-86. Scores of 41 and below indicate "evening types". Scores of 59 and above indicate "morning types". Scores between 42 and 58 indicate "intermediate types" in Morningness Eveningness Questionnaire
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
6-minute walking test
Description
An increase in the distance walked indicates improvement in basic mobility.
Time Frame
10 minutes
Title
30-second sit to stand test
Description
The wide variety of ability levels indicates with high scores
Time Frame
10 minutes
Title
Ferrans&Powers Quality of Life
Description
High scores indicates high Quality of life in individuals with diabetes
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34820
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
An article will be published at the end of this study. IIPD can be accessed with this article.
Citations:
PubMed Identifier
30426166
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.
Results Reference
result
PubMed Identifier
35606229
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.
Results Reference
derived
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The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
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