Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes

Launched by UNIVERSITY OF ADELAIDE · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how calcium affects gut functions and blood sugar levels in men with Type 2 diabetes. Researchers want to find out if infusing a solution with calcium chloride (a common form of calcium) into the small intestine can help improve these functions compared to a saline solution (saltwater) that serves as a control. Eligible participants are males aged 65 to 75 with Type 2 diabetes, who are stable in weight and meet specific blood sugar criteria.

If you decide to participate, you will attend three separate study sessions, each lasting 4 to 6 hours, where you will receive either saline, 500 mg of calcium chloride, or 1000 mg of calcium chloride, but you won't know which one you get during each session. There will be a break of a few days between each session. It’s important to know that certain health conditions and medications can make you ineligible for this study, so make sure to check the specific criteria. Overall, this study aims to help us better understand the role of calcium in managing diabetes.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Males with type 2 diabetes mellitus (T2DM), (BMI: 28-38 kg/m2), will be included in the study. Only men will be included in the study to avoid the confounding effects of the menstrual cycle on gastric emptying. 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 (i.e. \<5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.
• Exclusion Criteria:
• • 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