[PDF][PDF] An investigator-initiated, randomized, placebo-controlled clinical trial of substrate metabolism, insulin sensitivity, and body composition
MM Poulsen, PF Vestergaard, BF Clasen, Y Radko… - Diabetes, 2013 - Citeseer
MM Poulsen, PF Vestergaard, BF Clasen, Y Radko, LP Christensen, H Stødkilde-Jørgensen…
Diabetes, 2013•CiteseerRESEARCH DESIGN AND METHODS Ethical approval. All participants were given oral and
written information before written informed consent was obtained. The protocol was
approved by the Regional Committee on Health Research Ethics and the Danish Data
Protection Agency, and the study was conducted in agreement with the Declaration of
Helsinki II. According to the International Committee of Medical Journal Editors, the protocol
was registered at clinicaltrials. gov (NCT01150955) before recruitment was initiated …
written information before written informed consent was obtained. The protocol was
approved by the Regional Committee on Health Research Ethics and the Danish Data
Protection Agency, and the study was conducted in agreement with the Declaration of
Helsinki II. According to the International Committee of Medical Journal Editors, the protocol
was registered at clinicaltrials. gov (NCT01150955) before recruitment was initiated …
RESEARCH DESIGN AND METHODS
Ethical approval. All participants were given oral and written information before written informed consent was obtained. The protocol was approved by the Regional Committee on Health Research Ethics and the Danish Data Protection Agency, and the study was conducted in agreement with the Declaration of Helsinki II. According to the International Committee of Medical Journal Editors, the protocol was registered at clinicaltrials. gov (NCT01150955) before recruitment was initiated.
Subjects. Twenty-four male volunteers, aged 18–70 years, participated. All participants were obese (BMI. 30 kg/m2) but otherwise healthy, were taking no prescriptive medicine, and had no overt endocrine disorders. Eligibility
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