MaasFlex: A Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study to Evaluate the Effects of 2 Weeks Dapagliflozin Treatment on Nocturnal Substrate Oxidation, Glucose Metabolism and Muscle Mitochondrial Function in Individuals with Impaired Glucose Homeostasis - MAASFLEX

School of Nutrition and Translational research in Metabolism (NUTRIM), Maastricht University0 个研究点目标入组 17 人开始时间: 2018年12月19日最近更新: 2021年7月26日

适应症

试验速览

暂无简介。

•1. Provision of signed and dated informed consent prior to any study specific procedures.
•2. Males aged = 40 and = 75 years and post-menopausal women (defined as at least 1 year post cessation of menses) aged = 50 and = 75 years
•3. Body mass index (BMI) = 27 and = 38 kg/m2.
•4. Sedentary lifestyle (not more than 2 hours of vigorous exercise per week).
•5. Stable dietary habits.
•6. Impaired glucose homeostasis based on one or a combination of the following criteria:
•- Impaired Glucose Tolerance (IGT): plasma glucose values = 7.8 mmol/l and = 11.1 mmol/l 120 minutes after consumption of the glucose drink during the 2h, 3-point OGTT.
•- Impaired Fasting Glucose (IFG): fasting plasma glucose = 6.1 mmol/l and = 6.9 mmol/l.
•- Insulin Resistance: glucose clearance rate = 360 ml/kg/min, as calculated by Oral Glucose Insulin Sensitivity 120 (OGIS120) model based on the 2h, 3-point OGTT.
•- HbA1c = 5.7% and = 6.4%.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 13

•1. Clinical diagnosis of Type 1 or 2 Diabetes Mellitus.
•2. Active cardiovascular disease
•3. Weight gain or loss > 5 kg in the last 3 months, ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.
•4. Regular smoking and other regular nicotine use.
•5. Anaemia.
•6. Uncontrolled hypertension.
•7. Clinically significant abnormalities in clinical chemistry or hematology
•8. Unstable or rapidly progressing renal disease or estimated Glomeral Filtration Rate (eGFR) <60 mL/min (Cockcroft-Gault formula).
•9. Use of anti-coagulant treatment
•10. Use of medication such as oral glucocorticoids, anti-estrogens or other medications that are known to markedly influence insulin sensitivity.
•11. Use of loop diuretics.
•12. Intake of dietary supplements except multi-vitamins and minerals.
•13. Alcohol consumption of > 14 drinks per week for women and > 21 drinks per week for men.
•14. Known hypersensitivity to dapagliflozin or any of the excipients of the product.
•15. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
•16. Any contraindication for MRI scanning.

发起方

School of Nutrition and Translational research in Metabolism (NUTRIM), Maastricht University