Prediabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Participants will be randomized into the following two groups (ratio 3:1):
1. Intervention arm: 12-week partially supervised exercise training programme accompanied with dietary advice
2. Control arm
Sponsors
Dublin City University (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female adults 2. Aged 18-65 years 3. Impaired fasting glucose (6.1-7.0 mmol/l) or impaired glucose tolerance (7.0-11.1 mmol/l after a 2-hr oral glucose tolerance test) OR normal glucose tolerance but a score >12 on the FINDRISC questionnaire
Exclusion criteria
Exclusion criteria: 1. Individuals with diabetes, uncontrolled hypertension, cardiovascular disease, chronic lung disease, renal disease, active cancer, HIV infection, a seizure disorder or epilepsy, previous thyroid surgery or hyperthyroidism, chronic diarrhoea, being treated for obesity, chronic disabling conditions such as rheumatoid arthritis or Crohn's disease, or have had recent major surgery 2. Individuals who are pregnant or who are planning to become pregnant 3. Individuals with a peak aerobic capacity greater than 50 ml/kg/min 4. Individuals who have changed body weight >5% in the past month 5. Individuals who are found to have clinically significant abnormalities on routine lab testing 6. Individuals who have a positive response to the exercise stress test 7. Individuals who are unable to stay in the same geographic location for the duration of the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Fat distribution by assessment of subcutaneous and visceral fat through Ultrasonography (at baseline and 3 months after baseline) 2. Heart rate variability using the VAGUS apparatus (at baseline and 3 months after baseline) 3. Objectively measured physical activity by 7-day accelerometer assessment using ActiGraph (at baseline, 3 months after baseline, and 9 months after baseline) 4. Physical and mental health by questionnaires (SF-36, Benefits and Barriers Questionnaire, self-efficacy questionnaire) (at baseline, 3 months after baseline, and 9 months after baseline) 5. Dietary assessment (3-day semi-quantitative food diary) (at baseline and 3 months after baseline) 6. Pulse wave velocity using the SphygmoCor XCEL System (at baseline and 3 months after baseline) (in a subsample) | — |
Primary
| Measure | Time frame |
|---|---|
| 1. Transcriptomic, epigenetic, lipidomic and metabolic function by applying appropriate omics techniques in muscle and serum samples (at baseline, 3 months after baseline, and 9 months after baseline) 2. Insulin sensitivity by analysis of blood samples following intake of af glucose solution (plasma glucose and insulin from a 6-point oral glucose tolerance test) (at baseline and 3 months after baseline) 3. Fitness using the Vo2 Peak Test (at baseline and 3 months after baseline) 4. Adiposity (body composition by DEXA scanning and bio-impedance analysis, waist circumference, hip circumference, BMI) (at baseline and 3 months after baseline) | — |
Countries
Ireland
Outcome results
None listed