Mechanisms of prevention of type 2 diabetes by lifestyle intervention in subjects with pre-diabetes or at high risk for progressio

Not Applicable

Completed

• Conditions: Prediabetes; Diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN66987085
• Lead Sponsor: Dublin City University (Ireland)

Brief Summary

2014 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/25125339 study methods 2015 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26581687 protocol 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38599278/ (added 11/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-06
• Study Completion: 2015-06-30
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 373

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>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)<br>3. Fitness using the Vo2 Peak Test (at baseline and 3 months after baseline)<br>4. Adiposity (body composition by DEXA scanning and bio-impedance analysis, waist circumference, hip circumference, BMI) (at baseline and 3 months after baseline)

Secondary Outcome Measures

Name	Time	Method
1. Fat distribution by assessment of subcutaneous and visceral fat through Ultrasonography (at baseline and 3 months after baseline)<br>2. Heart rate variability using the VAGUS apparatus (at baseline and 3 months after baseline)<br>3. Objectively measured physical activity by 7-day accelerometer assessment using ActiGraph (at baseline, 3 months after baseline, and 9 months after baseline)<br>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)<br>5. Dietary assessment (3-day semi-quantitative food diary) (at baseline and 3 months after baseline)<br>6. Pulse wave velocity using the SphygmoCor XCEL System (at baseline and 3 months after baseline) (in a subsample)