Effects of education to self-care on the psychological and epigenetic profiles of people with type 2 diabetes

NeuroPsychological and EpiGenetic effects of structured group cAre for Self-management edUcation in patients with type 2 diabeteS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14558376

Enrollment

Registered

2015-03-12

Start date

2015-02-01

Completion date

Unknown

Last updated

2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. T2DM is characterised by increased circulating blood glucose levels that require constant attention to appropriate lifestyle behaviours to prevent the onset of long-term complications. 2. Group self-management education is proven to be effective in achieving good control of blood glucose and reduce the risk of complications. Nutritional, Metabolic, Endocrine T2DM

Interventions

GC-naïve patients attending a diabetes clinic in Turin (Italy) with T2DM for at least 1 year will be randomly allocated to GC or to continue usual care: 1. The systemic approach to GC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. GC-naive patients attending the diabetes clinic in Turin (Italy) 2. T2DM for at least 1 year 3. Aged 40-70 years old

Exclusion criteria

Exclusion criteria: 1. Current insulin treatment 2. Psychiatric conditions 3. Use of drugs affecting psychological functioning 4. Presence of diseases with reduced life expectancy 5. Planning pregnancy

Design outcomes

Primary

Measure	Time frame
1. Measurements of psychological profile with questionnaires translated into and validated in Italian: 1.1. Rosenberg Self Esteem Scale 1.2. Hospital Anxiety and Depression Scale 1.3. Locus of Control questionnaire 1.4. Diabetes Quality of Life questionnaire 2. Epigenetic profile of differentially methylated regions of DNA and histones across the genome These outcomes were measured at months 0 and 24.	—

Measure

Time frame

1. Measurements of psychological profile with questionnaires translated into and validated in Italian: 1.1. Rosenberg Self Esteem Scale 1.2. Hospital Anxiety and Depression Scale 1.3. Locus of Control questionnaire 1.4. Diabetes Quality of Life questionnaire 2. Epigenetic profile of differentially methylated regions of DNA and histones across the genome These outcomes were measured at months 0 and 24.

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Secondary

Measure	Time frame
1. Glycated haemoglobin, measured at months 0, 3, 6, 9, 12, 15, 18, 21 and 24 2. Total cholesterol, measured at months 0, 12 and 24 3. High-density lipoprotein cholesterol, measured at months 0, 12 and 24 4. Low-density lipoprotein cholesterol, measured at months 0, 12 and 24 5. Triglycerides, measured at months 0, 12 and 24 6. Serum creatinine, measured at months 0, 12 and 24 7. Blood pressure, measured at months 0, 3, 6, 9, 12, 15, 18, 21 and 24 8. Bodyweight, measured at months 0, 3, 6, 9, 12, 15, 18, 21 and 24 9. Progression of retinopathy, measured at months 0, 12 and 24 10. Microalbuminuria, measured at months 0, 12 and 24 11. Symptoms of neuropathy, measured at months 0, 12 and 24	—

Measure

Time frame

1. Glycated haemoglobin, measured at months 0, 3, 6, 9, 12, 15, 18, 21 and 24 2. Total cholesterol, measured at months 0, 12 and 24 3. High-density lipoprotein cholesterol, measured at months 0, 12 and 24 4. Low-density lipoprotein cholesterol, measured at months 0, 12 and 24 5. Triglycerides, measured at months 0, 12 and 24 6. Serum creatinine, measured at months 0, 12 and 24 7. Blood pressure, measured at months 0, 3, 6, 9, 12, 15, 18, 21 and 24 8. Bodyweight, measured at months 0, 3, 6, 9, 12, 15, 18, 21 and 24 9. Progression of retinopathy, measured at months 0, 12 and 24 10. Microalbuminuria, measured at months 0, 12 and 24 11. Symptoms of neuropathy, measured at months 0, 12 and 24

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Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026