None listed
Conditions
Brief summary
This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in normal weight, overweight or obese type 2 diabetic patients. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in type 2 diabetic patients.
Interventions
Assessment of blood glucose and gastric emptying, following administration of control, or 10g L-Leucine, or 10g L-Isoleucine 30 min prior to a standardised mixed nutrient drink. Subjects will receive, in randomized, double-blind fashion: i) an intragastric bolus infusion of 10g L-Leucine (100ml); ii) an intragastric bolus infusion of 10g L-Isoleucine (100ml); iii) an intragastric bolus infusion of saline (control) (100ml). Subjects will receive one infusion per visit. All bolus infusion will be administered by the primary researcher. Study visits will be separated by 3-7 days. In addition, during study visits, the primary researcher will be present in order to closely monitor adherence to study protocol. For each study visit a baseline blood sample, VAS, and breath sample will be collected (t = -31). At t = -31 the infusion will be administered over 1 minute using a feeding tube. At t = -20, -10, and -1 min further blood samples will be collected and VAS completed. At t = -1 min, subjects will consume, within 1 minute, a mixed-nutrient drink (Resource Plus, 500 kcal, 325 ml) labeled with 100 mg of 13C-acetate for measurement of gastric emptying by breath sampling, and 3g 3-OMG for measurement of glucose absorption. Blood samples and VAS will be taken every 15 minutes, and breath samples will be taken every 5 min, over the next hour (t = 0 to 60 min). Over the following hour, VAS and blood samples will be collected every half hour (t = 90, 120), and breath samples collected every 15 min (t = 75, 90, 105, 120).
Sponsors
Study design
Eligibility
Inclusion criteria
A total of 14 lean, overweight or obese T2DM (BMI 19-37 kg/m2) male and female subjects, aged between 18 - 70 years, will be included in the study. T2DM diagnosis will be based on WHO criteria (i.e. HbA1c will be >=6.5 - <=7.9%). Patients will be diet-controlled or required to cease oral blood glucose lowering medication 48 hours before participatiing in the study. All subjects will be required to be weight stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceeding 4 weeks. Subjects will be required to maintain their normal physical activity over the course of the study, which will be assessed using diaries. Females will be required to be postmenopausal.
Exclusion criteria
Significant gastrointestinal symptoms, disease or surgery; Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.) Lactose intolerance/other food allergy(ies) Current gallbladder or pancreatic disease Cardiovascular or respiratory diseases Those with low ferritin levels (less than 30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above) High performance athletes Current intake of greater than 2 standard drinks on greater than 5 days per week Current smokers of cigarettes/cigars/marijuana Current intake of any illicit substance Vegetarians Inability to comprehend study protocol Restrained eaters (score >12 on the three factor eating questionnaire). The degree of eating restraint will be assessed for all, but not used as an exclusion criteria for overweight or obese subjects, as overweight and obese often have some degree of eating restraint HbA1c <6.5% - >7.9%; metformin medication >2g/d Estimated glomerular filtration rate <45ml/min