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临床试验/NCT04416204
NCT04416204已完成不适用

Role of Hepatic Glycogen on Nocturnal EGP in T2D

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年8月21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
34
试验地点
2
主要终点
Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes

研究概览

简要总结

The experimental approach in this study intends to investigate the role of hepatic glycogen content on nocturnal regulation of endogenous glucose production including the relative contributions of glycogenolysis and gluconeogenesis and the extent to which this differs between subjects with type 2 diabetes and subjects without diabetes. Both participants with type 2 diabetes and participants without diabetes will be studied after consuming either a low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.

详细描述

Physiology study for looking at glycogen loading vs non loading in improving nightime glucose tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

盲法说明

A total of 34 subjects participated.

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30-75
  • BMI 20-35kg/m^2
  • Participants with type 2 diabetes:
  • HbA1c less than or equal to 8.5% on lifestyle therapy or monotherapy with metformin or sulphonylureas (SU); or less than or equal to 7.5% on two oral hypoglycemic agents (Metformin and SU)

排除标准

  • Pregnancy or breast feeding
  • Morbidities precluding participation
  • Participants with type 2 diabetes:
  • Therapy with insulin
  • SGLT2 inhibitors
  • GLP-1 based approaches
  • Unstable diabetic retinopathy
  • Microalbuminuria
  • Macrovascular disease
  • Medications affecting GI motility (eg., erythromycin, pramlintide)
  • Upper GI disorder/surgery
  • Participants without diabetes:
  • Medications (except stable thyroid hormone or hormone replacement therapy) that could influence glucose tolerance
  • History of diabetes mellitus in first degree family members or prior history of diabetes mellitus or gestational diabetes, or pre-diabetes

结局指标

主要结局

Hepatic Glycogen Content and Rates of Gluconeogenesis in Subjects With Type 2 Diabetes

时间窗: Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks

We measured the rates and contribution of Gluconeogenesis (GNG) to nocturnal Endogenous Glucose Production (EGP) using the deuterated water technique after either glycogen loading or no glycogen loading in subjects with type 2 diabetes.

次要结局

  • Rates of Glycogenolysis in Subjects With Type 2 Diabetes(Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks)
  • Rates of Gluconeogenesis in Healthy Subjects(Subjects will complete both glycogen loading and no glycogen loading visits within approximately 6 weeks)

研究者

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

Rita Basu

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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