NCT06942195Recruiting
Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes
Effects of Intraduodenal Calcium on Plasma Glucose, Glucoregulatory Hormones and Gastric Emptying in Response to a Mixed-nutrient Drink in Humans With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 22 May 2025
- Primary completion date
- 28 Mar 2026
- Lead sponsor
- University of Adelaide
- Diseases
- Type 2 diabetes
- NCT number
- NCT06942195
What you commit to
- Study type: Interventional
- Planned participants: 8
- From 22 May 2025 to the primary completion date, 28 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
- Individuals with low ferritin levels (\<30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
- Current use of recreational drugs, e.g. marijuana
- Any patient whose medication cannot be withheld for 48 hours for medical reasons
Other illness
- 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)
- Lactose intolerance/other food allergy(ies)
Lab values
- HbA1c \<6% or \>7.9%
Other
- 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 intake of any illicit substance
- Vegetarians
- Inability to tolerate nasoduodenal tube
- Inability to comprehend study protocol
- Estimated glomerular filtration rate \<45 ml/min
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Facility, Adelaide Health and Medical Sciences Building Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.