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

NARECRUITING

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.

Study details:

Participants will be required to consume a standardised dinner meal (beef lasagne; total energy content: 602 kcal; McCain Food, Wendouree, Victoria, Australia) the night before each visit by no later than 7 pm. After fasting for \~ 13. 5 hours overnight and refraining from exercise and alcohol during the previous 24 hours, participants will arrive in the laboratory at 8.

30 am. After confirming adherence to the study requirements, their vital signs, including blood pressure, heart rate and body temperature, will be measured to establish baseline values for safety, and they will be monitored throughout the study. Then, a manometric catheter will be inserted through an anaesthetised nostril and allowed to pass through the stomach and into the duodenum by peristalsis.

The infusion port will be positioned \~ 14 cm distal to the pylorus. The correct positioning of the catheter will be monitored continuously by measurement of the transmucosal potential difference in the stomach (\~ -40 mV) and the duodenum (\~ 0 mV). Once the catheter has been positioned correctly, an intravenous cannula will be placed into a forearm vein for regular blood sampling.

At t = -30 min, a baseline blood sample (7 ml), visual analogue scale (VAS) questionnaire to assess GI symptoms and breath sample to assess gastric emptying will be collected. Then infusion of one of the study treatments (i. e.

i) saline, ii) 500 mg CaCl2 or iii) 1000 mg CaCl2) will commence and continue for 75 minutes (t = -30 to t = 45). At t = -1 min, participants will consume, within 1 min, a mixed-nutrient drink (350 mL, containing 500 kcal, 74 g carbohydrates) labelled with 100 mg 13C-acetate for measurement of gastric emptying by non-invasive breath sampling at regular intervals, for subsequent analysis of 13CO2. Blood samples for the measurement of plasma hormone concentrations and glucose, and VAS scores, will be collected before and after the mixed-nutrient drink.

At t = 240 min, after collecting final blood and breath samples and VAS scores, the i. v. cannula will be removed and participants will be served a light lunch, after which they will be allowed to leave the laboratory.

A total of 98 mL of blood (14 sampling time points, 7 mL each) will be taken on each study day (study total of 310 mL, including screening and glucose tolerance test samples).

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Males with type 2 diabetes mellitus (T2DM), (BMI: 28-38 kg/m2), will be included in the study.
  2. Only men will be included in the study to avoid the confounding effects of the menstrual cycle on gastric emptying.
  3. T2DM diagnosis will be based on WHO criteria.
  4. HbA1c will be >=6.5 - <=7.9% at screening.
  5. Blood glucose medications will be required to be withheld for 48 hours prior to each study day.
  6. All participants will be required to be weight-stable (i.e. <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.

Exclusion criteria

  1. Significant GI symptoms, or history of GI disease or surgery
  2. Current gallbladder or pancreatic disease
  3. Cardiovascular or respiratory diseases
  4. Any other illnesses (except type 2 diabetes) as assessed by the investigator - (including chronic illnesses not explicitly listed above)
  5. 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.)
  6. Lactose intolerance/other food allergy(ies)
  7. Individuals with low ferritin levels (<30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
  8. High performance athletes
  9. Current intake of > 2 standard drinks on > 5 days per week (>140g/week)
  10. Current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)
  11. Current use of recreational drugs, e.g. marijuana
  12. Current intake of any illicit substance Vegetarians
  13. Inability to tolerate nasoduodenal tube
  14. Inability to comprehend study protocol
  15. HbA1c <6% or >7.9%
  16. Estimated glomerular filtration rate <45 ml/min
  17. Any patient whose medication cannot be withheld for 48 hours for medical reasons

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: MALE

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

OTHER

phase

Phase

    NA

trial

Study ID

NCT06942195

Intervention or treatment

OTHER: Ca-1000

OTHER: Ca-500

OTHER: Control

Conditions

  • T2DM

  • Condition: T2DM

  • OTHER: Ca-1000 and other drugs

  • Adealide, South Australia, Australia

  • Sponsor: University of Adelaide

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Research sites nearby

Closest Location:

Clinical Research Facility, Adelaide Health and Medical Sciences Building

Select from list below to view details:

  • Clinical Research Facility, Adelaide Health and Medical Sciences Building

    Adealide, South Australia, Australia

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Who is running the clinical trial?

UoA

University of Adelaide

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: Ca-1000
  • In this arm, participants will receive a 75-minute intraduodenal infusion of an isotonic solution containing 3.68 g of calcium chloride dihydrate (CaCl₂·2H₂O), dissolved in 225 mL of distilled water.
Other: Ca-1000
    ACTIVE_COMPARATOR: Ca-500
    • In this arm, participants will receive a 75-minute intraduodenal infusion of an isotonic solution containing 1.84 g of calcium chloride dihydrate (CaCl₂·2H₂O), dissolved in 225 mL of distilled water. Additionally, 1.2 g of sodium chloride (NaCl) will be added to ensure the solution is isosmotic (300 mOsm).
    Other: Ca-500
      PLACEBO_COMPARATOR: Control
      • In this arm, participants will receive a 75-minute intraduodenal infusion of saline (an isotonic solution containing 2.8 g of sodium chloride (NaCl), dissolved in 225 mL of distilled water).
      Other: Control

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        Plasma glucose concentrationsPlasma glucose concentrations (mmol/L) will be assessed using glucose oxidase method.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 Outcome

        MeasureDescriptionTime Frame
        Gastric emptying13C-acetate breath test, measuring 13CO2 concentrations in end-expiratory breath samples.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.
        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 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.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).
        GI symptoms (nausea and bloating) will be assessed as a composite secondary outcome.These will be measured using 100mm VAS.Visual Analogue ratings will be collected over 4.5 hours: at baseline (time = -30 minutes) and at regular intervals before and after the drink (times = -15, 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 210, 240 minutes).
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

        Clinical Trials Gov: Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes

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