NL-OMON40307已完成不适用
The effect of cold acclimation on human brown adipose tissue and skeletal muscle mitochondrial uncoupling -a comparison in obesity and type 2 diabetes - Cold acclimation and brown fat - comparison in obesity and type 2 diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •* Caucasians
- •o Obese without type 2 diabetes: 18-65 years
- •o Obese with type 2 diabetes: 18-65 years
- •* BMI: 28-35 kg/m2
- •* Fat percentage: > 23%
- •* Gender: Male
- •* Specifically for obese subjects with type 2 diabetics:
- •o Diagnosed with type 2 diabetes at least 1.5 years before the start of the study
- •o Well-controlled type 2 diabetes: HBA1C < 8.5%
- •o Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
- •o No signs of active diabetes-related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy.
- •o No signs of active uncontrolled hypertension, liver of kidney malfunction
- •* Specifically for obese subjects without type 2 diabetes:
- •o Fasting blood glucose level <6.1 mmol/l
- •o No signs of active cardiovascular disease, uncontrolled hypertension, liver of kidney malfunction.
排除标准
- •* Participate in physical activity more than 2x/week
- •* Participation in earlier research that included a PET/CT-scan
- •* Radiation therapy due to medical treatment
- •* Unstable body weight (weight gain or loss > 5 kg in the last three months)
- •* Participation in another biomedical study within 1 month before the first screening visit;* Specifically for obese subjects without type 2 diabetes:
- •o Elevated fasting blood glucose level (> 6.1 mmol/L);* Specifically for obese subjects with type 2 diabetes:
- •o Impaired kidney- and/or hepatic function
- •o Diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, and retinopathy.
- •o Insulin dependent diabetic subjects
研究者
相似试验
已完成
不适用
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG (PN-1007) in anti-MAG neuropathy patients.anti-MAG neuropathyauto-immune10012303NL-OMON49059Polyneuron Pharmaceuticals AG9
已完成
不适用
Establishing a Female-only Controlled Human Schistosoma mansoni Infection Model: a safety and dose finding study (CoHSI2)SchistosomiasisbilharziaNL-OMON54881eids Universitair Medisch Centrum22
已完成
不适用
A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignanciesbeenmergstoornis: MDS (myelodysplastisch syndroom/myelodysplasie)cancer of the blood10024324Acute myeloid leukemiamyelodysplastic SyndromeNL-OMON55859Amgen10
已完成
3 期
The effect of Caphosol on the development of esophagitis in (N)SCLC patients treated with concurrent chemo/radiotherapy10038666Esofagitisesophagusinflammation1001796910069888NL-OMON39628Amphia Ziekenhuis55
已完成
不适用
A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination with cemiplimab in Adult Patients with Advanced Solid TumorsAdvanced solid tumors10027655NL-OMON55468Genzyme Europe BV12
