NCT07462078

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

The Effect of Lifestyle Modification on the Risk of Prediabetes Among Patients Attending Outpatient Clinic of Research Institute of Medical Entomology.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Diabetes is a worldwide epidemic and Type 2 DM (T2DM) accounts for nearly 90% of all diabetes cases worldwide. In Egypt, the prevalence of DM among adults was reported to be 15.2%. Recently it was estimated that 10.9 million had diabetes and this number is expected to rise to 13 million by 2030. This makes Egypt rank in the 10th position among countries with highest prevalence of DM. Furthermore, reports indicate that 43% of patients with diabetes and most patients with prediabetes in Egypt are likely undiagnosed. Type 2 diabetes, which makes up the bulk of diabetes cases, is largely preventable and, in some cases, potentially reversible if identified and managed early in the disease course. IT doesn't usually appear all of a sudden; many people have a long, slow, invisible lead-in to it called prediabetes. Prediabetes precedes T2DM, and in most of the cases, it ultimately leads to the development of diabetes. There are no clear symptoms of prediabetes; Some people with prediabetes may have some of the symptoms of diabetes or even problems from diabetes already. The single sign of prediabetes is elevated blood glucose on a blood test that is not high enough to be classified as type 2 diabetes mellitus. Criteria for diagnosing Prediabetes are elevated Glycated hemoglobin (Hba1C), impaired fasting plasma glucose (IFPG), impaired glucose tolerance (IGT), and both IFPG together with IGT. Cutoff levels indicating prediabetes are Hba1c of 5.7-6.4%, Fasting blood glucose of 100-125 mg/dL and 2-hour Oral Glucose Tolerance Test (OGTT) of 140-199 mg/dL. The 2-hour OGTT is laborious to perform, and results are inconsistent. FPG is commonly used in both clinical and epidemiological studies, but patients need to fast overnight. HbA1c detection is more convenient, more accurate with less pre-analytical and analytical variability; its use to diagnose diabetes has been widely recommended. The prevalence of prediabetes is high and is increasing rapidly in all parts of the world. It was reported to affect 1 in 3 adults in the US and approximately 720 million individuals worldwide. In Egypt, the prevalence of prediabetes in a community-based sample was found to be 21.7%. In a convenience sample of 352 employees at Faculty of Medicine, Ain Shams University, 36% were at high risk and 65.4% of high-risk participants were confirmed to be Prediabetic (23.6% of total sample). It was slightly lower among adults attending PHC in Al Bahah city, KSA (20%, around 21% in males and 19% in females of all ages). The main risk factors that strongly influence abnormal glycemic level are age, being physically inactive, previous history of abnormal glycemic level and waist circumference. Other factors include aging, smoking, obesity (central obesity), hypertension, and a family history of DM . Prediabetes is associated with increased risk of diabetes, cardiovascular events, and mortality. Approximately 10% of people with prediabetes progress to having diabetes each year. The progression of prediabetes to overt T2DM is around 25% within 3 to 5 years and as many as 70% of them will be manifested with diabetes within their lifetime. Therefore, identifying those individuals with prediabetes is crucial and cost-effective for reducing the incidence of diabetes. Pre-diabetes is a reversible condition. Early detection of prediabetes through screening is paramount for providing timely intervention and support, reducing the risk of T2DM and associated health complications. The screening process for prediabetes is the same as for type 2 diabetes and it relies on clinical risk factors. Recently, many trials have been made to develop simple, fast, non-invasive, and practical screening tools for prediabetes. The Finnish Diabetes Risk Score (FINDRISC) is a noninvasive and practical tool originally planned in Finland to recognize individuals at high risk of T2DM, without the required laboratory tests. The FINDRISC questionnaire was used by registered dietitians as part of the regular process during nutritional evaluation. High risk individuals detected by the screening test are subjected to blood glucose testing to confirm the diagnosis of prediabetes. The First-line therapy for prediabetes is lifestyle modification that includes weight loss and exercise or metformin. Lifestyle modification is associated with a larger benefit than metformin. Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 \[95% CI 0·61 to 0·91\]), and reduced the levels of Hba1C by 0·15% \[-0·25 to -0·05\], fasting plasma glucose by 3·44 mg/dL \[-4·72 to -2·17\], and 2-hr glucose tolerance by 4·18 mg/dL \[-7·35 to -1·02\]. Adopting a well-balanced diet, staying active, controlling your weight can put you in control, enabling you to arrest or even reverse the process. The behavioral lifestyle intervention, quietly known as diabetes prevention program (DPP), has turned into the standard for powerful strategies to prevent T2DM by overweight management, favorable diet planning and physical activity achievements. The two major targets of the DPP, behavioral, lifestyle involvement was to enhance and maintain a minimum of 7% weight loss and 150 min of physical exercise per week like in strength to brisk walking. Lifestyle, especially diet, forms the actual foundation of treatment to enhance blood glucose, lipid profile and blood pressure level, and decrease the rate of cardiovascular morbidity and mortality in those individuals. The general goal of nutrition intervention in people with prediabetes or DM2 is to help them improve their nutrition habits to prevent and/or delay the disease, enhance their metabolic condition, treat associated complications, and control or enhance their quality of life. Weight loss is related to enhancing glycemic control: the larger the weight loss, the greater the improvement in Hba1C. Nutrition counseling of the prediabetics regarding dietary and lifestyle modification is recommended so as to improve their metabolic control, thus preventing them from being diabetics. Physical activity is a safe, and cost-effective approach, which can help people with prediabetes to obtain different goals, as reducing metabolic syndrome and managing obesity. People who lose about 7% of their weight and do physical activity (30 min/day) increase insulin sensitivity and have \> 90% risk reductions of diabetes. The establishment of a nationwide program in Egypt for early detection of undiagnosed DM and those at risk of developing DM with comprehensive intervention measures for lifestyle modification was highly recommended. Implementation of risk screening and lifestyle changes for those at risk at the Research Institute of Medical Entomology is a step forward to provide evidence for the large-scale implementation of such effective intervention.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle modification	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.

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-05-02
• Completion: 2025-06-02
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Egypt