Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes
NCT ID: NCT06942195
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8 participants
INTERVENTIONAL
2025-05-22
2026-04-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Ca-1000
In this arm, participants will receive a 75-minute intraduodenal infusion of an isotonic solution containing 3.68 g of calcium chloride dihydrate (CaCl₂·2H₂O), dissolved in 225 mL of distilled water.
Ca-1000
Calcium, an essential mineral and a key component of dairy, is a regular part of our daily diet. Recent studies have shown that calcium, at doses of 1000 mg, stimulates gut hormones and motility, will be 'higher dose' in this condition.
Ca-500
In this arm, participants will receive a 75-minute intraduodenal infusion of an isotonic solution containing 1.84 g of calcium chloride dihydrate (CaCl₂·2H₂O), dissolved in 225 mL of distilled water. Additionally, 1.2 g of sodium chloride (NaCl) will be added to ensure the solution is isosmotic (300 mOsm).
Ca-500
Calcium, an essential mineral and a key component of dairy, is a regular part of our daily diet. Recent studies have shown that calcium, at doses of 500 mg, stimulates gut function. In this condition, it will be considered 'lower dose.'
Control
In this arm, participants will receive a 75-minute intraduodenal infusion of saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).
Control
Saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).
Interventions
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Ca-1000
Calcium, an essential mineral and a key component of dairy, is a regular part of our daily diet. Recent studies have shown that calcium, at doses of 1000 mg, stimulates gut hormones and motility, will be 'higher dose' in this condition.
Ca-500
Calcium, an essential mineral and a key component of dairy, is a regular part of our daily diet. Recent studies have shown that calcium, at doses of 500 mg, stimulates gut function. In this condition, it will be considered 'lower dose.'
Control
Saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
MALE
No
Sponsors
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University of Adelaide
OTHER
Responsible Party
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Christine Feinle-Bisset
Professor Christine Feinle-Bisset
Principal Investigators
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Prof Christine Feinle-Bisset
Role: 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
Locations
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Clinical Research Facility, Adelaide Health and Medical Sciences Building
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Parisa Rouhani, MsC
Role: primary
Other Identifiers
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13243-1
Identifier Type: -
Identifier Source: org_study_id