Status:
RECRUITING
Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes
Lead Sponsor:
University of Adelaide
Conditions:
T2DM
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
The intervention in this study consists of a 75-min intraduodenal infusion of an isotonic solution containing either of calcium chloride (CaCl2) or control (saline). Participants enrolled into the st...
Detailed Description
Each participant will be required to consume a standardised dinner meal (beef lasagne; total energy content: 602 kcal; McCain Food, Wendouree, Victoria, Australia) on the night before each visit by 7 ...
Eligibility Criteria
Inclusion
- Males with type 2 diabetes mellitus (T2DM). Diagnosis of T2DM will be based on WHO criteria. Only males will be included to avoid the confounding effects of the menstrual cycle on gastric emptying.
- BMI: 28-38 kg/m².
- HbA1c \>=6.5 - \<=7.9% at screening.
- Blood glucose medications will be required to be withheld for 48 hours prior to each study day.
- Weight-stable (i.e. \<5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 3 months.
Exclusion
- 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
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06942195
Start Date
May 22 2025
End Date
April 28 2026
Last Update
December 26 2025
Active Locations (1)
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1
Clinical Research Facility, Adelaide Health and Medical Sciences Building
Adelaide, South Australia, Australia, 5005