NCT03889977

Brief Summary

It is known that postprandial hyperglycemia increases the cardiometabolic risk in both diabetic and non-diabetic patients. Moreover, there is insufficient data on the effectiveness of exercise on preventing Type II diabetes mellitus in individuals with insulin resistance and prediabetes. This study aims to examine the effectiveness of resistance exercise in limiting postprandial hyperglycemia and the necessity of prescribing medication particularly in patients with beta-thalassemia and insulin resistance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 11, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

March 22, 2019

Last Update Submit

January 14, 2020

Conditions

Beta-ThalassemiaInsulin ResistancePreDiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

  • Changes in blood glucose

    Concentration of blood glucose will be measured in serum

    Pre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exercise

  • Changes in blood insulin

    Concentration of blood insulin will be measured in serum

    Pre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exercise

  • Changes in blood triglycerides

    Concentration of blood triglycerides will be measured in serum

    Pre-breakfast (fasting glucose), 45 min post-breakfast (before exercise), immediately post-exercise, 1 hour post-exercise, 2 hours post-exercise, 24 hours post-exercise

Secondary Outcomes (11)

  • Body mass

    At the baseline and before each trial

  • Body height

    At the baseline

  • Body fat

    Before each trial

  • Resting heart rate

    At the baseline and before each trial

  • Heart rate during exercise

    During exercise in each trial

  • +6 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Resistance exercise 45 min following breakfast

Other: Resistance exercise

Control

NO INTERVENTION

No exercise (resting) following breakfast

Interventions

Resistance exerciseOTHER

2 major muscle groups (lower extremity, chest)

Exercise

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with Beta-Thalassemia
  • Diagnosed with prediabetes or type II diabetes

You may not qualify if:

  • Heart failure
  • Hypertension
  • Muscular, neuromuscular, bone disorders
  • Muscular, bone or other injuries that do not allowed safe participation to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Biochemistry Laboratory, School of Physical Education & Sports Sciences, University of Thessaly

Trikala, 42100, Greece

Location

MeSH Terms

Conditions

beta-ThalassemiaInsulin ResistancePrediabetic StateDiabetes Mellitus, Type 2

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alexandra Stamperna, MD

    UNIVERSITY OF THESSALY, SCHOOL OF PHYSICAL EDUCATION & SPORTS SCIENCES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 22, 2019

First Posted

March 26, 2019

Study Start

February 11, 2019

Primary Completion

August 30, 2019

Study Completion

October 30, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

GR(1)