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临床试验/NCT03683888
NCT03683888已完成不适用

Effect of a Personalized Nutritional and Exercise Algorithm to Epicardial Fat in Patients With Obesity and Pre-Diabetes

University of Miami2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Epicardial fat thickness (EAT)

研究概览

简要总结

The purpose of this research study is to learn about the effectiveness of HealthSnap assessment, to reduce epicardial fat thickness. Excessive epicardial fat is associated with higher risk of developing diabetes and heart diseases. HealthSnap Assessment is a simple, quick and not invasive tool that will provide the patient with a personalized information nutritional and exercise plan.The use of HealthSnap in the clinical practice has not been evaluated, yet.

详细描述

This study will evaluate the practicality of adding the HealthSnap algorithm to the standard care of patients with overweight/obesity and pre-diabetes.

Participants will be recruited among the outpatient population who routinely refer to the Lennar Foundation Comprehensive Diabetes Center Outpatient Clinics, Division of Endocrinology, Diabetes and Metabolism University of Miami, for standard care and management of diabetes, obesity, overweight, hypertension, dyslipidemia.

Once patient eligibility and written consent are obtained, participant is then scheduled for the clinic visit through the University of Miami UChart (Epic) electronic system. The visits will be coordinated by the research coordinator. At each visit each patient will undergo:

  • Full physical examination, body weight, height, waist and hip circumference, blood pressure (standard of care)
  • Fasting blood glucose and haemoglobinA1c (HbA1c), lipid panel, comprehensive metabolic panel, fasting insulin, C-peptide and pro-insulin (all procedures are standard of care)
  • Ultrasound assesment of epicardial fat, performed on site
  • HealthSnap assessment performed on site (if randomized to the group receiving additional Healthnap)
  • Standard of care dietary counselling performed on site by a registered dietitian (if randomized to the control group)

Study patients and controls will be contacted by the dietitian and/or HealthSnap supervisor once a week via telephone, or email (Uchart) or via online session (collaborate Ultra) to monitor their compliance and adherence to the exercise and dietary program.

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
None

入排标准

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

入选标准

  • Body mass index (BMI) ≥ 27 kg/m2
  • HbA1c 5.7-6.5% within 3 months the initial visit and/or
  • Fasting blood glucose (FBG) 100-125 mg/dl within 3 months the initial visit and/or
  • Family history for diabetes or CAD or dyslipidemia

排除标准

  • • Type 1 diabetes
  • Pregnancy
  • Mental illness preventing correct use of HealthSnap
  • Physical inability to follow HealthSnap recommendations
  • Active infective and neoplastic diseases
  • No current diabetes medications with the exception of Metformin
  • Chemotherapy

结局指标

主要结局

Epicardial fat thickness (EAT)

时间窗: 3 months

Change in ultrasound measured EAT

次要结局

  • Body Mass Index (BMI)(3 months)
  • Hemoglobin A1c (HbA1c) percentage (%)(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Iacobellis

Professor of Medicine

University of Miami

研究点 (2)

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