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

• Register: ISRCTN
• Last refreshed on: 31 August 2020
• Main ID: ISRCTN14558376
• Date of registration: 12/03/2015
• Prospective Registration: No
• Primary sponsor: Department of Medical Sciences
• Public title: Effects of education to self-care on the psychological and epigenetic profiles of people with type 2 diabetes
• Scientific title: NeuroPsychological and EpiGenetic effects of structured group cAre for Self-management edUcation in patients with type 2 diabeteS
• Date of first enrolment: 01/02/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14558376
• Study type: Interventional
• Study design: Randomised controlled single-centre study (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Massimo Porta

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 includes seven 1-hour sessions held 3 months apart and the cycle is repeated every 2 years.
2. The curriculum covers burden of overweight, choosing food and meal planning, physical exercise, monitoring and improving metabolic control, smoking cessation, taking medication properly and preventing complications.
3. Education is mostly through group work, hands-on activities, problem-solving, real-life simulations and role playing.
4. One to two members of the team (doctor, educator or psychologist) act as facilitators in groups of up to 10 patients, who remain in the same groups over time.
5. Patients in the control arm will receive standard care in the form of one-to-one consultations with the doctor and yearly checks/refreshment of their knowledge of diabetes.
6. Both arms will receive yearly screening for complications.
7. All clinical activities will be carried out in the Laboratorio di Pedagogia Clinica at the San Giovanni Antica Sede Hospital in Turin (Italy), affiliated with the main Città della Salute e della Scienza di Torino (Italy).
8. Questionnaire administration and blood sample processing will be done by qualified collaborators.
9. Once stocked, specimens will be sent to laboratories of a hospital in Turin for routine clinical tests and to the Genetics of Diabetes Laboratory of Naples Federico II University (Italy) for epigenetic analyses.

Primary Outcome(s)

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.

Secondary Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Ricerca Finalizzata del Ministero della Salute Repubblica Italiana (Italy)

Ethics review

Status:
Approval date:
Contact:

Comitato Etico Interaziendale A.O.U. San Giovanni Battista di Torino - A.O. C.T,O./Maria Adelaide di Torino" (Joint Ethics Committee of the San Giovanni Battista di Torino and A.O. C.T,O./Maria Adelaide di Torino hospitas in Turin, Italy), 07/03/2011, serial no. CEI/177

Results

• Results available: Yes
• Date Completed: 31/03/2019