Actively Recruiting
Effects of Intraduodenal Calcium on Plasma Glucose, Glucoregulatory Hormones and Gastric Emptying in Response to a Mixed-nutrient Drink in Men With Type 2 Diabetes
Led by University of Adelaide · Updated on 2025-12-26
8
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of calcium on gut function and blood sugar control in men with type 2 diabetes. The study aims to understand how intraduodenal infusion of calcium chloride at different doses influences plasma glucose levels, gut hormones, gastric emptying, and gastrointestinal symptoms. This research is conducted by the University of Adelaide and involves a randomized, triple-blind study design. Participants will receive three separate 75-minute infusions through a catheter placed into the duodenum. The infusions include saline (control), 500 mg calcium chloride, or 1000 mg calcium chloride, given in random order over sessions spaced at least 4 days apart. Each session lasts 4 to 6 hours and includes careful monitoring with blood sampling, breath tests, and symptom questionnaires. During each visit, participants will fast overnight and consume a standardized meal before arrival. Blood pressure, heart rate, and temperature are checked, and an intravenous line is placed for blood sampling. Blood and breath samples will be collected at multiple times before and after ingestion of a mixed-nutrient drink to measure glucose, hormones, and gastric emptying. Gastrointestinal symptoms will be assessed using questionnaires. After the final collection, participants receive a light lunch and leave. Total blood drawn per participant during the study is about 310 mL including screening.
CONDITIONS
Brief Title
Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male with type 2 diabetes mellitus diagnosed by WHO criteria
- Body mass index (BMI) between 28 and 38 kg/m²
- HbA1c between 6.5% and 7.9% at screening
- Blood glucose medications withheld for 48 hours prior to each study day
- Stable body weight with less than 5% fluctuation in the past 3 months
You will not qualify if you...
- Significant gastrointestinal symptoms or history of gastrointestinal disease or surgery
- Current gallbladder or pancreatic disease
- Cardiovascular or respiratory diseases
- Other illnesses besides type 2 diabetes as assessed by the investigator
- Use of medications or supplements affecting metabolism, gastrointestinal function, bodyweight, or appetite
- Lactose intolerance or other food allergies
- Low ferritin levels (<30 ng/mL) or blood donation in the prior 12 weeks
- High performance athletes
- Drinking more than 2 standard alcoholic drinks on more than 5 days per week
- Current tobacco smoking or vaping
- Current use of recreational or illicit drugs
- Vegetarian diet
- Inability to tolerate nasoduodenal tube
- Inability to understand the study protocol
- HbA1c below 6% or above 7.9%
- Estimated glomerular filtration rate below 45 ml/min
- Medication cannot be withheld for 48 hours for medical reasons
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment visit lasts approximately 4.5 hours
Participants receive a 75-minute intraduodenal infusion of either saline, 500 mg calcium chloride, or 1000 mg calcium chloride, followed by consumption of a mixed-nutrient drink. Blood samples, breath samples, and gastrointestinal symptom questionnaires are collected before, during, and after the infusion and drink consumption to assess glucose levels, hormone concentrations, gastric emptying, and GI symptoms.
Multiple visits for each treatment arm in a crossover design
Trial Site Locations
Total: 1 location
1
Clinical Research Facility, Adelaide Health and Medical Sciences Building
Adelaide, South Australia, Australia, 5005
Actively Recruiting
Research Team
P
Prof Christine Feinle-Bisset
P
Penelope Fitzgerald, MsC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
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