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Completed

NCT Number: NCT06603480

Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2. Abdülhamid Han Training and Research Hospital

Üsküdar, Istanbul, 34660, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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

Metformin

Other

Patients who started Metformin 2*1

Primary outcomes

  1. MGO

    Time frame: 1 week

    Methylgloxal level

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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