Type 2 DiabetesCircadianNCT04427488
The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
A study testing Morning Chronotype group and Evening Chronotype group in people with Type 2 Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Morning Chronotype group and Evening Chronotype group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 15 Oct 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Morning Chronotype group, Evening Chronotype group
- Keywords
- Circadian Rhthym, Exercise, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Chronotype groupOther
Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
Evening Chronotype groupOther
Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
| Study group | Role | What they receive |
|---|---|---|
| Morning Chronotype (MC) Group | Experimental | 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. Receives: Other: Morning Chronotype group |
| Evening Chronotype (EC) Group | Experimental | The EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks Receives: Other: Evening Chronotype group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c evaluation
Blood sample scores are changeable
Measured: 3 hours
Fasting glucose evaluation
Blood sample are changeable
Measured: 3 hours
HDL (high density lipoprotein) evaluation
Blood sample are changeable
Measured: 3 hours
LDL (low density lipoprotein) evaluation
Blood sample are changeable
Measured: 3 hours
Total cholesterol evaluation
Blood sample are changeable
Measured: 3 hours
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
Measured: 10 minutes
Secondary outcomes (3)
6-minute walking test
An increase in the distance walked indicates improvement in basic mobility.
Measured: 10 minutes
30-second sit to stand test
The wide variety of ability levels indicates with high scores
Measured: 10 minutes
Ferrans&Powers Quality of Life
High scores indicates high Quality of life in individuals with diabetes
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Aug 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve yilmaz menek, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427488
- Sponsor's protocol ID
- merveymz
- Acronym
- Circadian
- Status last verified
- Dec 2021
- First submitted
- 8 Jun 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: An article will be published at the end of this study. IIPD can be accessed with this article.
Publications
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.
PubMed 30426166Menek 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.
PubMed 35606229
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04427488
- Acronym / sponsor ID
- Circadian / merveymz
- Conditions
- Type 2 Diabetes
- Keywords
- Circadian Rhthym, Exercise, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 Jun 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Chronotype (MC) Group | Experimental | Other: Morning Chronotype groupIn 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. |
| Evening Chronotype (EC) Group | Experimental | Other: Evening Chronotype groupThe EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Morning Chronotype groupTotal of 12 weeks aerobic and strengthening exercises in different timing of the day. | Other | Morning Chronotype (MC) Group |
| Evening Chronotype groupTotal of 12 weeks aerobic and strengthening exercises in different timing of the day. | Other | Evening Chronotype (EC) Group |
Primary outcome
HbA1c evaluation
Time frame: 3 hours
Blood sample scores are changeable
Fasting glucose evaluation
Time frame: 3 hours
Blood sample are changeable
HDL (high density lipoprotein) evaluation
Time frame: 3 hours
Blood sample are changeable
LDL (low density lipoprotein) evaluation
Time frame: 3 hours
Blood sample are changeable
Total cholesterol evaluation
Time frame: 3 hours
Blood sample are changeable
Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire
Time frame: 10 minutes
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
3 secondary outcomes
6-minute walking test
Time frame: 10 minutes
30-second sit to stand test
Time frame: 10 minutes
Ferrans&Powers Quality of Life
Time frame: 10 minutes
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 3 Jan 2022.
- Results publication: PubMed 30426166Savikj 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.
- Derived from this study: PubMed 35606229Menek 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.
- Individual participant dataSharing planned: No. An article will be published at the end of this study. IIPD can be accessed with this article.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Chronotype group and Evening Chronotype group in people with Type 2 Diabetes, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 6 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 3 Jan 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 Turkey (Türkiye). 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?
HbA1c evaluation (time frame: 3 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427488, which also lists 2 linked publications.
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 3 Jan 2022.