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
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
Treatments tested in this trial
- Ca-1000
- Ca-500
- Control
Treatment groups
8 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov