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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06942195




Registration number
NCT06942195
Ethics application status
Date submitted
8/04/2025
Date registered
24/04/2025
Date last updated
24/04/2025

Titles & IDs
Public title
Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes
Scientific title
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
Secondary ID [1] 0 0
13243-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
T2DM 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ca-1000
Other interventions - Ca-500
Other interventions - Control

Active comparator: 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.

Active comparator: 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).

Placebo comparator: 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).


Other interventions: 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.

Other interventions: 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.'

Other interventions: Control
Saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma glucose concentrations
Timepoint [1] 0 0
Blood samples will be collected over 4.5 hours: at baseline (time = -30 minutes), then at regular intervals before and after drink administration (times = -25, -15, 0, 10, 20, 30, 45, 60, 75, 90, 120, 180, 240 minutes).
Secondary outcome [1] 0 0
Gastric emptying
Timepoint [1] 0 0
Breath samples will be collected in sealed tubes over 4.5 hours: at baseline (time = -30 minutes) (prior to treatment administration), every 5 minutes after the drink (times = 0 to 60 minutes), then every 10 minutes until 240 minutes post-drink.
Secondary outcome [2] 0 0
Plasma concentrations of glucoregulatory hormones e.g. glucagon-like peptide (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), C-peptide, glucagon, insulin and cholecystokinin (CCK)
Timepoint [2] 0 0
Blood samples will be collected over 4.5 hours: at baseline (time = -30 minutes), then at regular intervals before and after the drink (times = -25, -15, 0, 10, 20, 30, 45, 60, 75, 90, 120, 180, 240 minutes).
Secondary outcome [3] 0 0
GI symptoms (nausea and bloating) will be assessed as a composite secondary outcome.
Timepoint [3] 0 0
Visual Analogue ratings will be collected over 4.5 hours: at baseline (time = -30 minutes) and at regular intervals before and after the drink (times = -15, 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 210, 240 minutes).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
28/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/04/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Clinical Research Facility, Adelaide Health and Medical Sciences Building - Adealide
Recruitment postcode(s) [1] 0 0
5005 - Adealide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Christine Feinle-Bisset
Address 0 0
Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Prof Christine Feinle-Bisset
Address 0 0
Country 0 0
Phone 0 0
+61 8 8313 6053
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06942195