The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes (Circadian)

December 30, 2021 updated by: merve yilmaz menek, Istanbul Medipol University Hospital
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34820
        • İstanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Morning Chronotype (MC) Group
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.
Other: Morning Chronotype group
Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
EXPERIMENTAL: Evening Chronotype (EC) Group
The EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks
Other: Evening Chronotype group
Total of 12 weeks aerobic and strengthening exercises in different timing of the day.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c evaluation
Time Frame: 3 hours
Blood sample scores are changeable
3 hours
Fasting glucose evaluation
Time Frame: 3 hours
Blood sample are changeable
3 hours
HDL (high density lipoprotein) evaluation
Time Frame: 3 hours
Blood sample are changeable
3 hours
LDL (low density lipoprotein) evaluation
Time Frame: 3 hours
Blood sample are changeable
3 hours
Total cholesterol evaluation
Time Frame: 3 hours
Blood sample are changeable
3 hours
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
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
6-minute walking test
Time Frame: 10 minutes
An increase in the distance walked indicates improvement in basic mobility.
10 minutes
30-second sit to stand test
Time Frame: 10 minutes
The wide variety of ability levels indicates with high scores
10 minutes
Ferrans&Powers Quality of Life
Time Frame: 10 minutes
High scores indicates high Quality of life in individuals with diabetes
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • merveymz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

An article will be published at the end of this study. IIPD can be accessed with this article.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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