Effects of combined administration of L-tryptophan and lauric acid on gastric emptying of, and the gut and glucoregulatory hormone and postprandial blood glucose responses to, a mixed-nutrient drink in humans with type 2 diabetes

Christine Feinle-Bisset0 个研究点目标入组 15 人开始时间: 2023年7月18日最近更新: 2024年5月21日

适应症

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•Male participants with type 2 diabetes mellitus (T2DM), (aged 18-75 years BMI: 28-38 kg/m2), will be included in the study. T2DM diagnosis will be based on WHO criteria. HbA1c will be >=6.5 - <=7.9% at screening. Blood glucose medications will be required to be withheld for 48 hours prior to each study day. All participants will be required to be weight-stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.

•Significant GI symptoms, or history of GI disease or surgery
•Current gallbladder or pancreatic disease
•Cardiovascular or respiratory diseases
•Any other illnesses (except type 2 diabetes) as assessed by the investigator (including chronic illnesses not explicitly listed above)
•Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, bodyweight or appetite (e.g. domperidone, cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
•Lactose intolerance/other food allergy(ies)
•Individuals with low ferritin levels (<30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
•High performance athletes
•Current intake of > 2 standard drinks on > 5 days per week (>140g/week)
•Current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)
•Current use of recreational drugs, e.g. marijuana
•Current intake of any illicit substance
•Vegetarians
•Inability to tolerate nasoduodenal tube
•Inability to comprehend study protocol
•HbA1c <6% or >7.9%
•Estimated glomerular filtration rate <45 ml/min
•Any patient whose medication cannot be withheld for 48 hours for medical reasons

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