Effects of acute and sub-acute treatment with metformin on cardiovascular responses to a glucose challenge in type 2 diabetes

Phase 4

Recruiting

• Conditions: type 2 diabetes; Metabolic and Endocrine - Diabetes; Cardiovascular - Normal development and function of the cardiovascular system

• Registration Number: ACTRN12619001060134
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet only
Body mass index (BMI) 25 - 35 kg/m2
Males and females, aged 40-80 years
Glycated haemoglobin (HbA1c) 6- 8.5%
Haemoglobin above the lower limit of the normal range (ie. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. >30ng/mL for men and >20mg/mL for women)
Patients on stable doses of antihypertensives will be included.

Exclusion Criteria

Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin)
Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
Other significant illness, including epilepsy, cardiovascular or respiratory disease
Impaired renal or liver function (as assessed by calculated creatinine clearance < 60 mL/min or abnormal liver function tests (> 2 times upper limit of normal range))
Donation of blood within the previous 3 months
Participation in any other research studies within the previous 3 months
Inability to give informed consent
Female participants who are not on long acting contraception
Previously unable to tolerate metformin or treatment with metformin within the past week.

Study & Design

• Study Type: Interventional
• Study Design: Not specified