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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04427488
Collaborator
(none)
30
1
2
16
1.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: Morning Chronotype group
  • Other: Evening Chronotype group
N/A

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

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes
Actual Study Start Date :
Jun 15, 2020
Actual Primary Completion Date :
Aug 15, 2021
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. HbA1c evaluation [3 hours]

    Blood sample scores are changeable

  2. Fasting glucose evaluation [3 hours]

    Blood sample are changeable

  3. HDL (high density lipoprotein) evaluation [3 hours]

    Blood sample are changeable

  4. LDL (low density lipoprotein) evaluation [3 hours]

    Blood sample are changeable

  5. Total cholesterol evaluation [3 hours]

    Blood sample are changeable

  6. Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire [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

Secondary Outcome Measures

  1. 6-minute walking test [10 minutes]

    An increase in the distance walked indicates improvement in basic mobility.

  2. 30-second sit to stand test [10 minutes]

    The wide variety of ability levels indicates with high scores

  3. Ferrans&Powers Quality of Life [10 minutes]

    High scores indicates high Quality of life in individuals with diabetes

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Istanbul Turkey 34820

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
merve yilmaz menek, Lecturer, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT04427488
Other Study ID Numbers:
  • merveymz
First Posted:
Jun 11, 2020
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by merve yilmaz menek, Lecturer, Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2022