Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
MALE
NCT06942195

Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes

Led by University of Adelaide · Updated on 2025-12-26

8

Participants Needed

1

Research Sites

48 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes

Who Can Participate

Age: 18Years - 70Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male with type 2 diabetes diagnosed by WHO criteria
  • Body mass index between 28 and 38 kg/m²
  • HbA1c between 6.5% and 7.9% at screening
  • Able to withhold blood glucose medications for 48 hours before each study day
  • Stable weight with less than 5% fluctuation in the last 3 months
Not Eligible

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
  • Any other illnesses except type 2 diabetes as judged by the investigator
  • Use of medications or supplements affecting metabolism, gastrointestinal function, body weight, or appetite
  • Lactose intolerance or other food allergies
  • Low ferritin levels (<30 ng/mL) or recent blood donation within 12 weeks
  • High performance athlete
  • Consuming more than 2 standard alcoholic drinks on more than 5 days per week
  • Current tobacco smoker or use of recreational drugs
  • Vegetarian diet
  • Unable to tolerate nasoduodenal tube placement
  • Unable to understand the study protocol
  • HbA1c below 6% or above 7.9%
  • Estimated kidney filtration rate below 45 ml/min
  • Unable to withhold medication for 48 hours due to medical reasons

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinical Research Facility, Adelaide Health and Medical Sciences Building

Adelaide, South Australia, Australia, 5005

Actively Recruiting

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Research Team

P

Prof Christine Feinle-Bisset

CONTACT

P

Penelope Fitzgerald, MsC

CONTACT

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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