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

ConditionT2DM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-70
SponsorUniversity of Adelaide

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Ca-1000

    Other intervention

    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.

  • Ca-500

    Other intervention

    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.'

  • Control

    Other intervention

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

Treatment groups

8 Participants
are divided into 3 treatment groups
Group A: Ca-1000Active comparator 1 intervention
Group B: Ca-500Active comparator 1 intervention
Group C: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Plasma glucose concentrations

Plasma glucose concentrations (mmol/L) will be assessed using glucose oxidase method.

Time frame
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 outcomes

1

Gastric emptying

13C-acetate breath test, measuring 13CO2 concentrations in end-expiratory breath samples.

Time frame
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.
2

Plasma concentrations of glucoregulatory hormones e.g. glucagon-like peptide (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), C-peptide, glucagon, insulin and cholecystokinin (CCK)

Plasma concentration of hormones e.g. GLP-1, GIP and CCK (pmol/L) will be determined using radioimmunoassays, and plasma C-peptide, glucagon and insulin concentrations (pmol/L) will be measured using ELISA immunoassays.

Time frame
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).
3

GI symptoms (nausea and bloating) will be assessed as a composite secondary outcome.

These will be measured using 100mm VAS questionnaire.

Time frame
Visual Analogue questionnaires will be collected over 4.5 hours: at baseline (time = -30 minutes), at regular intervals before and after the drink (times = -25, -15, 0, 20, 30, 45 minutes), then every 10 minutes until 240 minutes.

Other outcomes

Sponsors and contacts

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University of Adelaide

Lead sponsor

Source ClinicalTrials.gov
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