RecruitingNot ApplicableNCT06942195

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

Sponsor

University of Adelaide

Enrollment

8 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

T2DM

Summary

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how calcium intake affects digestion speed and blood sugar levels in men with type 2 diabetes, to understand whether calcium could be useful in managing blood glucose. **You may be eligible if...** - You are a man with type 2 diabetes - Your HbA1c (a measure of blood sugar control) is between 6.5% and 7.9% - Your BMI is between 28 and 38 kg/m² - Your weight has been stable over the past 3 months - You are willing to temporarily stop your diabetes medication for 48 hours before each study visit **You may NOT be eligible if...** - You are a woman (the study is limited to men to reduce hormonal variation) - You have a significant gastrointestinal condition or a history of GI surgery - You have gallbladder, pancreatic, heart, or lung disease - You are taking medications that affect gut function or metabolism - You have a food allergy such as lactose intolerance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCa-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.

OTHERCa-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.'

OTHERControl

Saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).

Locations(1)

Clinical Research Facility, Adelaide Health and Medical Sciences Building

Adelaide, South Australia, Australia

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NCT06942195

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