Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals

NCT ID: NCT06603480

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2022-12-07

Brief Summary

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The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

Detailed Description

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There is no comparative study in the literature evaluating the effects of exercise and metformin on MGO in prediabetic patients. The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

Conditions

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Methylglyoxal PreDiabetes Exercise Metformin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic Exercise

12 week aerobic exercise

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Aerobic exercise (moderate intensity) at 50-70% of maximum heart rate for 60 minutes, 3 days a week for 12 weeks

Metformin

Metformin 2\*1 given

Group Type EXPERIMENTAL

Metformin

Intervention Type OTHER

Patients who started Metformin 2\*1

Control

Only routine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Aerobic exercise (moderate intensity) at 50-70% of maximum heart rate for 60 minutes, 3 days a week for 12 weeks

Intervention Type BEHAVIORAL

Metformin

Patients who started Metformin 2\*1

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
* who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
* who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
* who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
* who had the same weight (±2.5 kg) for 6 months before participating in the study.

Exclusion Criteria

* having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
* having used metformin for 6 months before the study, having cardiovascular disease,
* heart failure, cancer, having a BMI \<19 kg/m2, receiving hormone replacement therapy,
* having a life expectancy of less than 1 year, being HIV positive, substance use,
* functional dependence, having an orthopedic disease that prevents physical activity,
* having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.),
* using medications or supplements that would affect the study results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sultan 2. Abdülhamid Han Training and Research Hospital

Üsküdar, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MEGS

Identifier Type: -

Identifier Source: org_study_id

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