NCT06942195 Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes
| NCT ID | NCT06942195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Adelaide |
| Condition | T2DM |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2026-03-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 8 participants in total. It began in 2025-05-22 with a primary completion date of 2026-03-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 study will receive, in randomised, double-blind fashion (i) Saline (control), (ii) 500 mg CaCl2, or (iii) 1000 mg CaCl2 in three separate sessions, each of which will be separated by at least 4 (and up to 10) days. Each study session will be 4-6 hours. Studies will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide, by staff and students trained in the required techniques.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Prof Christine Feinle-Bisset
PRINCIPAL INVESTIGATOR
Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Frequently Asked Questions
Who can join the NCT06942195 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 70 Years, studying T2DM. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06942195 currently recruiting?
Yes, NCT06942195 is actively recruiting participants. Contact the research team at christine.feinle@adelaide.edu.au for enrollment information.
Where is the NCT06942195 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT06942195 clinical trial?
NCT06942195 is sponsored by University of Adelaide. The principal investigator is Prof Christine Feinle-Bisset at Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005. The trial plans to enroll 8 participants.