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

NCT04891887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2021-05-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Health education program

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.

Sponsors & Collaborators

  • Science and Technology Development Fund (STDF)

    collaborator UNKNOWN

  • National Research Centre, Egypt

    lead OTHER

Principal Investigators

  • Iman I Salama, MD · National Research Centre, Egypt

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891887 on ClinicalTrials.gov