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临床试验/NCT07462078
NCT07462078已完成4 期

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

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年9月25日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
124
试验地点
1
主要终点
FIND risk score questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 70 years old.
  • Both sexes.
  • Read and write.
  • Prediabetic as detected by:
  • FINDRISC score of ≥
  • 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.

排除标准

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

研究组 & 干预措施

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)

干预措施: Lifestyle modification (Behavioral)

Non-intervention

No Intervention

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

结局指标

主要结局

FIND risk score questionnaire

时间窗: 2 months

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

次要结局

  • 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)
  • Assessment of lifestyle quality(6 months)
  • Glucose tolerance test measurement(6 months)
  • Glycated hemoglobin measurement(6 months)
  • Assessment of change of Waist circumferance(6 months)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Samy Mohamed Marei

Principal investigator

Kasr El Aini Hospital

研究点 (1)

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