NCT03379792已完成不适用
The Influence of Glycemic Control and Obesity on Energy Balance and Metabolic Flexibility in Type 1 Diabetes
AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年3月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Energy Expenditure
研究概览
简要总结
The purpose of this study is to measure the metabolic phenotype of a range of body weights in individuals with and without type 1 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 19 to 30 years of age, inclusive.
- •Type 1 Diabetes Cohort:
- •Diagnosis of type 1 diabetes for greater than 1 year at screening.
- •Hemoglobin A1c 6.5-13% or
- •Control Cohort Without Diabetes:
- •a. Healthy individuals without diabetes matched to T1D cohort by BMI and gender
- •Able to provide informed consent.
- •BMI 18-39.9 kg/m^2
排除标准
- •Type 2 diabetes
- •History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, clinically significant abnormalities on EKG, presence of cardiac pacemaker, implanted cardiac defibrillator)
- •Liver disease (AST or ALT >2.5 times the upper limit of normal), history of hepatitis
- •Kidney disease (creatinine >1.6 mg/dl or estimated glomerular filtration rate (GFR)<60 ml/min)
- •Dyslipidemia, including triglycerides >800 mg/dl, LDL >200 mg/dl
- •Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
- •Thyroid dysfunction (suppressed thyroid-stimulating hormone (TSH), elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
- •Uncontrolled hypertension (BP >160 mmHg systolic or > 100mmHg diastolic)
- •History of cancer within the last 5 years (skin cancers, with the exception of melanoma, may be acceptable).
- •Initiation or change in hormone replacement therapy within the past 3 months (including, but not limited to thyroid hormone, birth control or estrogen replacement therapy)
- •History of organ transplant
- •History of HIV, active Hepatitis B or C, or Tuberculosis
- •Pregnancy, lactation or 6 months postpartum from screening visit
- •History of major depression
- •Psychiatric disease prohibiting adherence to study protocol
- •History of eating disorders
- •Cushing's disease or syndrome
- •History of bariatric surgery
- •Tobacco use within the past 3 months
- •History of drug or alcohol abuse (≥3 drinks per day) within the last 5 years
- •Use of oral or injectable anti-hyperglycemic agents (except insulin)
- •Current use of beta-adrenergic blocking agents
- •Use of antibiotics within the past 3 months
- •Weight >450 lbs (This is DEXA table weight limit)
- •Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening
- •Unable to participate in MRI or magnetic resonance spectroscopy (MRS) assessment based on Investigator's judgment at screening
- •Participants with strict dietary concerns (e.g. vegetarian or kosher diet, multiple food allergies, or allergies to food we will provide them during the study)
- •Gastrointestinal disorders including: inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis.
- •Presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participant's ability to complete study visits
结局指标
主要结局
Energy Expenditure
时间窗: 24 hours
Measured via whole room calorimetry; based on oxygen consumption and carbon dioxide production measured using gas analyzers, as well as 14-hour urinary nitrogen excretion; calculated using established equations.
次要结局
未报告次要终点
研究者
研究点 (1)
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