Diabetes Mellitus and microRNA as Risk Factors for Mild Cognitive Impairment: Impact of Life Style Modification

NCT04891887 | Completed

• 1 other identifier: 15026
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2-step study; 1st step was a cross sectional study carried out on 163 consecutive Type 2 Diabetes Mellitus (T2DM) patients employee attending outpatient clinics of the National Research Center (NRC), Egypt. A face-to-face interview was carried out to collect data about demographic data and medical history. Cognitive function assessment was carried out using Adenbrooke's Cognitive Examination III (ACE III) test and the Trail Making Test (TMT) which consists of two parts (A and B). Quality of life and depression were also assessed using Short Form-36 (SF-36) and Hamilton Depression Rating Scale (HRDS) questionnaires respectively. The second step was an interventional study for health education and life style modification. The main outcome measures were Fasting Blood Glucose (FBG), HbA1c, total blood cholesterol, HDL cholesterol, LDL cholesterol and triglycerides, oxidant and antioxidant (Malondialdehyde (MDA), glutathione peroxidase (GPx), glutathione reductase (GR)) which were assessed at baseline and reassessed after the intervention.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus; Health education; Depression; Quality of life; Healthy life style; Cognitive function

Outcome Measures

Primary Outcomes (4)

• HbA1c

  HbA1c

  6 months

• Cognitive function

  Total score of Adenbrooke's Cognitive Examination III. Minimum value= 0, maximum value= 100 and higher scores mean a better outcome.

  6 months

• Depression

  Hamilton Rating Scale for Depression score. Minimum value= 0, maximum value= 53 and higher scores mean a worse outcome.

  6 months

• Health related quality of life

  Short Form-36 (SF-36) questionnaire score. Minimum value= 0, maximum value= 100 and higher scores mean a better outcome.

  6 months

Secondary Outcomes (16)

• Malondialdehyde

  6 months

• Glutathione Reductase

  6 months

• Glutathione Peroxidase

  6 months

• Total serum cholesterol

  6 months

• LDL

  6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Health education program

Behavioral: Health education program

Interventions

Health education program BEHAVIORAL

Seven face to face sessions and group discussion health education sessions. Two prepared booklets were distributed to all attendants titled "Diabetes mellitus and how to control its complications" and "Mild cognitive impairment and how to prevent it". Lab results were discussed individually with each participant to discuss his adherence to the lifestyle modification program. Clinical follow-up and management with endocrinology and neurology specialists. Individualized Medical Nutrition. Participants were then counselled on healthy eating habits. Individualized biweekly follow-up scheme through mobile phone. A WhatsApp group was created for all participants to contact the research team whenever they have any inquiry concerning life style modifications. Through this group, 12 HE audio electronic messages were shared with participants. Final reassessment of clinical status and laboratory profile was carried out with participants who continued till the end of the study.

Intervention

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2DM patients attending outpatient clinics of Medical Services Unit of the National Research Center (NRC).

You may not qualify if:

• T2DM patients with history of head trauma, stroke, transient ischemic attack, brain tumor, epilepsy, psychiatric disease, cardiac or liver failure and visual or hearing disabilities

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Science and Technology Development Fund (STDF): collaborator

Study Sites (1)

National Research Centre

Giza, Egypt

Location

Related Publications (1)

• Salama II, Sami SM, Salama SI, Abdel-Latif GA, Aboulghate A, Raslan HM, Mohsen A, Rasmy H, Ibrahim MH, Ganem MM, Abdelmohsen AM, El-Etreby LA, Ibrahim NA, Fouad WA, El-Deeb SE. Impact of lifestyle modification on glycemic control and cognitive function among Type II diabetes mellitus patients. Future Sci OA. 2023 Mar 9;9(1):FSO835. doi: 10.2144/fsoa-2022-0060. eCollection 2023 Jan.

  PMID: 37006227 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Health Education; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms

Study Officials

• Iman I Salama, MD

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 19, 2021
• Study Start: February 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)