Effects of Hydroxycitrate (HCA) on intestinal glucose absorption and incretin release

Phase 2

Completed

• Conditions: Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12615000088549
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Healthy subjects:
- Males or females aged 18 – 70 years
- Body mass index (BMI) 19 - 30 kg/m2

Type 2 diabetes patients:
Patients with type 2 diabetes
- Patients with a diagnosis of type 2 diabetes by WHO criteria (plasma glucose greater than or equal to 7 mmol/L fasting, or greater than or equal to 11.1 mmol/L two hours after a glucose challenge) or with a history of HbA1c greater than or equal to 6.5%.
- Managed by diet alone.
- HbA1c between 6.0 and 8.5%
- Body mass index (BMI) 20 - 35 kg/m2
- Age 18 – 70 years

Exclusion Criteria

- Use of any medication that may influence gastrointestinal motor function within 48 hours or 5 half lives of the study, specifically: opiates, anticholinergics, levodopa, calcium-channel antagonists, beta blockers, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, erythromycin
- Intake of >20 g alcohol on a daily basis, or >10 cigarettes per day
- History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy)
- Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests)
- Donation of blood within the previous 3 months
- Participation of other studies within the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood glucose concentrations[Concentrations measured from venous blood taken at T = -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes]

Secondary Outcome Measures

Name	Time	Method
Serum 3-O-methylglucose concentrations[Concentrations measured from venous blood taken at T = 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes];Plasma total GLP-1 concentrations[Concentrations measured from venous blood taken at T = -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes];Plasma total GIP concentrations[Concentrations measured from venous blood taken at T = -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes];Plasma insulin concentrations[Concentrations measured from venous blood taken at T = -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes];Plasma glucagon concentrations[Concentrations measured from venous blood taken at T = -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes];Gastrointestinal sensations of hunger, fullness and nausea.[Assessed by visual analogue questionnaire completed at T = -60, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes]