NCT05884814

Brief Summary

The aims of the current study are

  1. 1.to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes.
  2. 2.to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

May 10, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

May 10, 2023

Last Update Submit

July 27, 2023

Conditions

Keywords

exercisecircadian rhythmglucose controlmusclestrength

Outcome Measures

Primary Outcomes (2)

  • Change in muscle strength

    Sum of one repetition maximum for the 7 resistance exercise

    Change from baseline to 12 weeks

  • Change in interstitial glucose time in range

    Interstitial glucose time in range (3.9-10mmol/L) measured via continuous glucose monitoring

    Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session

Secondary Outcomes (8)

  • Change in appendicular skeletal muscle mass

    Change from baseline to 12 weeks

  • Change in whole body fat mass

    Change from baseline to 12 weeks

  • Change in physical function

    Change from baseline to 12 weeks

  • Change in HbA1c

    Change from baseline to 12 weeks

  • Change in interstitial glucose average

    Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session

  • +3 more secondary outcomes

Study Arms (3)

Control

PLACEBO COMPARATOR

Habitual physical activity

Behavioral: Habitual physical activity levels

Morning exercise

ACTIVE COMPARATOR

Exercise training between 6-10am

Behavioral: Morning exercise

Afternoon exercise

ACTIVE COMPARATOR

Exercise training between 4-8pm

Behavioral: Afternoon exercise

Interventions

Between 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)

Morning exercise

Between 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)

Afternoon exercise

Participants will be asked to maintain their normal activity levels

Control

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Physician confirmed type 1 diabetes for at least 1 year
  • Stable insulin therapy for 3 months prior to the study

You may not qualify if:

  • BMI of 45 or higher
  • BP of 160/100mmHg or higher
  • autonomic neuropathy
  • severe proliferative retinopathy
  • joint or limb injuries preventing weight-bearing activity
  • autonomic neuropathy
  • severe proliferative retinopathy
  • any other medical condition that prevents participants from exercising safely.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, 15462, Kuwait

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1:1 parallel group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Medical Officer

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 1, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations