Effects of calcium and amino acids on gut hormone secretions and bone turnover in males with obesity (with or without impaired glucose tolerance or type 2 diabetes)
- Conditions
- obesityType 2 diabetesImpaired bone turnover physiologyImpaired glucose toleranceDiet and Nutrition - ObesityMusculoskeletal - Other muscular and skeletal disordersMetabolic and Endocrine - Other endocrine disordersMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12622000739718
- Lead Sponsor
- Christine Feinle-Bisset
- Brief Summary
Intraduodenal administration of calcium enhances the effect of Trp to suppress energy intake, associated with greater stimulation of GI hormones secretion, in healthy males with obesity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 15
15 male individuals (aged 18-70 yrs) with obesity (BMI: 28-38 kg/m2, waist circumference >= 102 cm), with or without impaired glucose tolerance (IGT), including type 2 diabetes (T2D), at screening, will be studied. At screening, HbA1c will be in the range of >=6% to <=7.9% and fasting blood glucose in the range of >=6.1 mmol/L to <7 mmol/L will be classified as IGT and fasting blood glucose >=7 mmol/L will be classified as type 2 diabetes. Blood glucose medications will be withheld for 48 hours prior to each study day. Participants will be required to be weight-stable (i.e. <5% fluctuation) at study entry; this will be ascertained by asking participants about any significant body weight change in the preceding 3 months and, if so, those individuals would be excluded.
Each participant will be questioned prior to the study to exclude:
-significant GI symptoms, disease or surgery
-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)
-current gallbladder or pancreatic disease
-cardiovascular or respiratory diseases
-individuals with low ferritin levels (males <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 > 2 standard drinks on > 5 days per week
-current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)
- recreational drug use, e.g marijuana
-current intake of any illicit substance
-vegetarians
-inability to tolerate nasoduodenal tube
-inability to comprehend study protocol
-restrained eaters (score >12 on the 3-factor eating questionnaire)
- HbA1c <6% or >7.9%
- any patient whose medication cannot be withheld for 48 hours for medical reasons;
- estimated glomerular filtration rate <45 ml/min
- autonomic nerve function damage, i.e. a score of =>3 from standardised cardiovascular reflex tests.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentrations of GI hormones (gastrin, CCK, GIP, GLP-1, and potentially other, including yet to be identified, gut hormones), and glucose. This outcome is of an exploratory nature so that specific hormones to be measured may be decided upon based on the effect of the intervention on this and other outcomes, therefore, this is a composite outcome.[ These will be assessed before infusion (t = -15, -5 min) and post-infusion commencement at regular time points for 3 hours (t= 5, 15, 30, 45, 60, 75, 80, 90, 105, 120, 135, 150, 180 min).];Plasma markers of bone remodelling and calcium homeostasis (CTX, PTH)[ These will be assessed before infusion (t = -15, -5 min) and post-infusion commencement at regular time points for 3 hours (t= 5, 15, 30, 45, 60, 75, 80, 90, 105, 120, 135, 150, 180 min).]
- Secondary Outcome Measures
Name Time Method