Small-intestine calcium infusion to change gut function and blood sugar in men with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized, double-blind, crossover design, participants attend three separate 4–6 hour clinic visits to receive a 75-minute intraduodenal infusion of either saline (control), 500 mg CaCl2, or 1000 mg CaCl2. A nasal catheter is passed into the duodenum and correct placement is confirmed electrically, while blood samples, breath tests for gastric emptying, and symptom questionnaires are collected before, during, and after the infusion. Visits are separated by 4–10 days and participants withhold glucose medications for 48 hours before each visit. The study measures plasma glucose, glucoregulatory hormones, gastric emptying, and gastrointestinal symptoms to see how intraduodenal calcium alters gut and glucose responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males with type 2 diabetes mellitus (T2DM). Diagnosis of T2DM will be based on WHO criteria. Only males will be included to avoid the confounding effects of the menstrual cycle on gastric emptying.
* 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:

* 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

Where it's running

• Clinical Research Facility, Adelaide Health and Medical Sciences Building
  Adelaide, South Australia, Australia Recruiting

Study contacts

• Principal investigator: Prof Christine Feinle-Bisset — Adelaide Medical School University of Adelaide Level 5 Adelaide Health and Medical Sciences Building, Cnr George St and North Tce, Adelaide, SA 5005
• Study coordinator: Prof Christine Feinle-Bisset
• Email: christine.feinle@adelaide.edu.au
• Phone: +61 8 8313 6053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.