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Timing of Resistance Exercise in Type 1 Diabetes (T-REX)

Primary Purpose

Type 1 Diabetes

Status

Recruiting

Phase

Not Applicable

Locations

Kuwait

Study Type

Interventional

Intervention

Morning exercise

Afternoon exercise

Habitual physical activity levels

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring exercise, circadian rhythm, glucose control, muscle, strength

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Physician confirmed type 1 diabetes for at least 1 year Stable insulin therapy for 3 months prior to the study Exclusion Criteria: 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.

Sites / Locations

Dasman Diabetes InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Morning exercise

Afternoon exercise

Arm Description

Habitual physical activity

Exercise training between 6-10am

Exercise training between 4-8pm

Outcomes

Primary Outcome Measures

Change in muscle strength

Sum of one repetition maximum for the 7 resistance exercise

Change in interstitial glucose time in range

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

Secondary Outcome Measures

Change in appendicular skeletal muscle mass

Measured by DEXA

Change in whole body fat mass

Measured by DEXA

Change in physical function

Measured by the short performance physical battery

Change in HbA1c

HbA1c concentration

Change in interstitial glucose average

Interstitial average glucose measured via continuous glucose monitoring

Change in interstitial glucose variability

Interstitial glucose variability measured via continuous glucose monitoring

Change in interstitial glucose time in hypoglycaemia

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

Change in interstitial glucose time in hyperglycaemia

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

Full Information

NCT ID

NCT05884814

First Posted

May 10, 2023

Last Updated

July 27, 2023

Sponsor

Dasman Diabetes Institute

1. Study Identification

Unique Protocol Identification Number

NCT05884814

Brief Title

Timing of Resistance Exercise in Type 1 Diabetes

Acronym

T-REX

Official Title

Timing of Resistance Exercise, Glucose Control and Exercise Adaptations in People With Type 1 Diabetes: a Randomised-controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dasman Diabetes Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

exercise, circadian rhythm, glucose control, muscle, strength

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1:1 parallel group design

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Habitual physical activity

Arm Title

Morning exercise

Arm Type

Active Comparator

Arm Description

Exercise training between 6-10am

Arm Title

Afternoon exercise

Arm Type

Active Comparator

Arm Description

Exercise training between 4-8pm

Intervention Type

Behavioral

Intervention Name(s)

Morning exercise

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Afternoon exercise

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Habitual physical activity levels

Intervention Description

Participants will be asked to maintain their normal activity levels

Primary Outcome Measure Information:

Title

Change in muscle strength

Description

Sum of one repetition maximum for the 7 resistance exercise

Time Frame

Change from baseline to 12 weeks

Title

Change in interstitial glucose time in range

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in appendicular skeletal muscle mass

Description

Measured by DEXA

Time Frame

Change from baseline to 12 weeks

Title

Change in whole body fat mass

Description

Measured by DEXA

Time Frame

Change from baseline to 12 weeks

Title

Change in physical function

Description

Measured by the short performance physical battery

Time Frame

Change from baseline to 12 weeks

Title

Change in HbA1c

Description

HbA1c concentration

Time Frame

Change from baseline to 12 weeks

Title

Change in interstitial glucose average

Description

Interstitial average glucose measured via continuous glucose monitoring

Time Frame

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

Title

Change in interstitial glucose variability

Description

Interstitial glucose variability measured via continuous glucose monitoring

Time Frame

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

Title

Change in interstitial glucose time in hypoglycaemia

Description

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

Time Frame

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

Title

Change in interstitial glucose time in hyperglycaemia

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ebaa AlOzairi, MBChB

Phone

+965 22242999

ebaa.alozairi@dasmaninstitute.rog

Facility Information:

Facility Name

Dasman Diabetes Institute

City

Kuwait City

ZIP/Postal Code

15462

Country

Kuwait

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ebaa AlOZairi

First Name & Middle Initial & Last Name & Degree

Ebaa AlOzairi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Timing of Resistance Exercise in Type 1 Diabetes

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