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临床试验/NCT04463277
NCT04463277已完成不适用

Therapeutic Effects of Time Restricted Feeding and Calorie Restriction in Patients With Prediabetes and Diabetes

Usman Bin Hameed1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
OGTT

研究概览

简要总结

This research aims to find an effective dietary intervention among the Pakistani population. According to WHO, diabetes is on the rise in developing countries; the current prevalence among the Pakistani population is 11.2% which is expected to increase in the coming years which is in line with the similar documented trend in neighboring south Asian countries.3,11 Since, ethnic south Asians carry a greater risk for developing T2D at a younger age and along with the complications associated with diabetes due to its chronicity, this poses a significant threat and an increased disease burden on the health care system.11

This will be the first trial conducted on determining the efficacy of caloric restriction in a subset of Pakistani population. There is limited inconsistent data on the efficacy of time-restricted feeding, however, this will help elucidate if it does lead to positive effects on the bio-health markers. One of the major hurdles in caloric restriction is patient compliance, therefore, one of the intervention group will be used to determine if TRF with caloric restriction helps improve the patient's compliance and produces significant results. If such an intervention is effective in inducing weight loss it can also be applied for other overweight patients. Eventually, it will help in countering the rising obesity in the region.

The ultimate purpose of the knowledge obtained is to find a patient friendly, novel and therapeutic dietary intervention which will help in limiting the rise in T2D patients. It'll help in introducing an effective lifestyle intervention to promote health, which will reduce the dependence on pharmacological therapies, as well as, in the long-term reduce burden on the health care system.

The information obtained can provide framework for new guidelines in helping the patients to lose weight, which can be utilized by the government to increase general awareness which will help prevent diseases linked to obesity. In light of the randomized controlled trial, the primary health physicians can educate and increase awareness regarding the different dietary interventions the patients can utilize which will help increase the number of options for the patients. Social media platforms can be utilized due to their extended outreach for the transmission of accurate information to the general population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Glycemic values belonging to diabetes or prediabetes category.
  • •Weight stable for at least 6 months prior to start of study.
  • •Ability to understand English and use English language mobile applications.

排除标准

  • •Pregnant or breastfeeding women.
  • •Diabetics taking insulin or sulfonylureas.
  • •History of cardiovascular disease.
  • •History of psychiatric or eating disorders.
  • •History of hypoglycemic episodes.

研究组 & 干预措施

Calorie Restriction

Experimental

干预措施: Calorie Restriction (Behavioral)

Time Restricted Feeding

Experimental

干预措施: Time Restricted Feeding (Behavioral)

Time Restricted Feeding with Calorie Restriction

Experimental

干预措施: Time Restricted Feeding with Calorie Restriction (Behavioral)

Control

No Intervention

结局指标

主要结局

OGTT

时间窗: 12 weeks

Change in participants' response to an oral glucose load.

HbA1c

时间窗: 12 weeks

Change in percentage of glycated hemoglobin HbA1c in the participants' plasma.

FBS

时间窗: 12 weeks

Change in participants' fasting plasma glucose levels.

Weight

时间窗: 12 weeks

Change in participants' weight.

Serum Lipid Profile.

时间窗: 12 weeks

Change in participant's serum lipid levels, including cholesterol, LDL, HDL and triglycerides.

次要结局

未报告次要终点

研究者

发起方
Usman Bin Hameed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Usman Bin Hameed

Principal Investigator

Aga Khan University

研究点 (1)

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