The Effect of Lifestyle Modification on the Risk of Prediabetes Among Patients Attending Outpatient Clinic.

NCT07462078 | Completed Phase 4 DMC

• 1 other identifier: MD-87-2024
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus is a major global health challenge, with type 2 diabetes (T2DM) accounting for nearly 90% of all cases worldwide. In Egypt, diabetes prevalence among adults is high (15.2%), with approximately 10.9 million people currently affected and projections estimating a rise to 13 million by 2030, placing Egypt among the top ten countries worldwide for diabetes prevalence. Alarmingly, a large proportion of diabetes and most prediabetes cases remain undiagnosed. Prediabetes is a common, asymptomatic, and reversible condition that precedes T2DM and is characterized by elevated blood glucose levels not meeting diagnostic thresholds for diabetes. Diagnostic criteria include impaired fasting plasma glucose, impaired glucose tolerance, and elevated HbA1c. Globally, prediabetes affects nearly one-third of adults, and in Egypt its prevalence ranges from 21-24% in community and occupational settings. Individuals with prediabetes face a significantly increased risk of progressing to T2DM, cardiovascular disease, and mortality, with up to 70% developing diabetes during their lifetime if left untreated. Early identification of prediabetes is essential and cost-effective. Non-invasive screening tools such as the Finnish Diabetes Risk Score (FINDRISC) provide a practical method for identifying high-risk individuals, who can then undergo confirmatory blood testing. Lifestyle modification is the cornerstone of prediabetes management and is more effective than pharmacological therapy alone. Evidence shows that modest weight loss, increased physical activity, and dietary improvements significantly reduce diabetes incidence and improve glycemic parameters. Structured lifestyle programs, particularly the Diabetes Prevention Program (DPP), have demonstrated substantial benefits through achieving at least 7% weight loss and 150 minutes of moderate physical activity per week. Establishing nationwide screening and lifestyle intervention programs in Egypt is strongly recommended to reduce the burden of diabetes. Local implementation initiatives provide critical evidence to support the scalability and effectiveness of such preventive strategies.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• FIND risk score questionnaire

  Early detection of patients at risk of diabetes (Prediabetic) using FIND risk score questionnaire

  2 months

Secondary Outcomes (9)

• Fasting blood glucose measurement

  6 months

• Knowledge, attitude and Practice questionnaire

  6 months

• Assessment of weight reduction

  6 months

• Compliance to nutrition plan

  6 months

• Compliance to Metformin assessment

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Each patient in the intervention group had received 6 sessions according to settled appointments to check the adherence of the patient to the nutrition plan, physical activity and adherence to Metformin (if prescribbed)

Behavioral: Lifestyle modification

Non-intervention

NO INTERVENTION

non-intervention group received nutrition education session at the end of the study

Interventions

Lifestyle modification BEHAVIORAL

A combination of interactive counseling, visual educational materials, audio reminders and mobile-based support tools was used to enhance participants' understanding, motivation and adherence to lifestyle modification recommendations. Printed visual aids, illustrated dietary guides, anthropometric feedback charts and physical activity posters were used during counseling sessions. Audio messages and phone reminders were delivered to reinforce behavioral change and improve compliance throughout the intervention period.

Also known as: Drug: Metformin

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 years old.
• Both sexes.
• Read and write.
• Prediabetic as detected by:
• FINDRISC score of ≥ 7.
• Confirmed by Fasting blood glucose of 100-125 mg/d L, OGTT of 140 -200 -mg/dL and Hba1c of 5.7-6.4 %
• Have a smart mobile.

You may not qualify if:

• Known diabetes mellitus patients.
• Known Malabsorption syndrome patients.
• Known allergic patients to some food items such as lactose intolerance.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Research Institute of Medical Entomology

Giza, Doki, 202, Egypt

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 10, 2026
• Study Start: September 25, 2024
• Primary Completion: May 2, 2025
• Study Completion: June 2, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

EG (1)