NCT04427488

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

June 8, 2020

Last Update Submit

December 30, 2021

Conditions

Keywords

Circadian RhthymExerciseType 2 Diabetes

Outcome Measures

Primary Outcomes (6)

  • HbA1c evaluation

    Blood sample scores are changeable

    3 hours

  • Fasting glucose evaluation

    Blood sample are changeable

    3 hours

  • HDL (high density lipoprotein) evaluation

    Blood sample are changeable

    3 hours

  • LDL (low density lipoprotein) evaluation

    Blood sample are changeable

    3 hours

  • Total cholesterol evaluation

    Blood sample are changeable

    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

    10 minutes

Secondary Outcomes (3)

  • 6-minute walking test

    10 minutes

  • 30-second sit to stand test

    10 minutes

  • Ferrans&Powers Quality of Life

    10 minutes

Study Arms (2)

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.

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

Other: Evening Chronotype group

Interventions

Total of 12 weeks aerobic and strengthening exercises in different timing of the day.

Morning Chronotype (MC) Group

Total of 12 weeks aerobic and strengthening exercises in different timing of the day.

Evening Chronotype (EC) Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 8, 2020

First Posted

June 11, 2020

Study Start

June 15, 2020

Primary Completion

August 15, 2021

Study Completion

October 15, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

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

Locations