Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000717752
Ethics application status
Approved
Date submitted
28/06/2013
Date registered
1/07/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of resveratrol supplementation on gut hormone secretion, gastric emptying, and blood glucose responses to meals in patients with type 2 diabetes
Scientific title
A randomised placebo controlled crossover trial to evaluate the effects of 5 weeks resveratrol supplementation on GLP-1 secretion, gastric emptying, and postprandial glycaemia in patients with type 2 diabetes mellitus
Secondary ID [1] 282754 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 289489 0
Condition category
Condition code
Metabolic and Endocrine 289816 289816 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each patient will undergo two 5 week treatment periods, one with resveratrol 500mg capsules twice daily and one with placebo, in double- blind, randomised fashion, separated by 5 weeks. They will attend the laboratory on the first and last day of each treatment period to consume a mashed potato meal labelled with 13C-octanoic acid. Compliance will be monitored by capsule counts at each study visit and by twice weekly telephone calls.
Intervention code [1] 287420 0
Treatment: Drugs
Comparator / control treatment
Matching placebo capsules
Control group
Placebo

Outcomes
Primary outcome [1] 289887 0
Plasma total GLP-1 concentrations
Timepoint [1] 289887 0
Concentrations measured at T = -5, 15, 30, 45, 60, 90, 120, 150, 180 and 240 min in relation to consumption of the test meal at T = 10 min
Secondary outcome [1] 303482 0
Gastric half-emptying time as measured by 13C-octanoic breath test
Timepoint [1] 303482 0
Breath samples collected at T=5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60 min and then every 15 min until T = 240 min
Secondary outcome [2] 303483 0
Blood glucose concentrations
Timepoint [2] 303483 0
Concentrations measured at T = -5, 15, 30, 45, 60, 90, 120, 150, 180 and 240 min in relation to consumption of the test meal at T = 10 min

Eligibility
Key inclusion criteria
- Patients with a diagnosis of type 2 diabetes by WHO criteria (plasma glucose 7 mmol/L or greater fasting, or 11.1 mmol/L or greater two hours after a glucose challenge) or with a history of HbA1c 6.5% or greater, managed by diet alone.
- Body mass index (BMI) 20 - 35 kg/m2
- Age 20 – 75 years
- Males and post-menopausal females (the latter based on history).
- HbA1c 7.9% or less
- Haemoglobin above the lower limit of the normal range (ie. >130g/L in males and 120g/L in females) and ferritin above the lower limit of normal (ie. >15 mcg/L in females and 30 mcg/L in males)
Minimum age
20 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of any medication, within a period of 5 half-lives or less before the study, that may influence gastrointestinal motor function (eg: 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, or erythromycin).
- Intake of > 20 g alcohol on a daily basis, or cigarette smoking
- Inability to tolerate the standardized meals (eg. strict vegetarians, subjects with food allergies such as egg allergy, and those on a gluten-free diet).
- History of gastrointestinal disease, including chronic abdominal symptoms or a diagnosis of gastroparesis
- Unstable cardiac disease, specifically those with cardiac symptoms such as angina or dyspnea, not adequately controlled by medications.
- Impaired renal function (eGFR of <60 mL/min/1.73 m2).
- Impaired liver function (liver enzymes twice the upper limit of normal or greater).
- Donation of blood within the previous 3 months
- Participation in any other research studies within the previous 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2013
Actual
30/09/2013
Date of last participant enrolment
Anticipated
Actual
22/08/2014
Date of last data collection
Anticipated
Actual
14/01/2015
Sample size
Target
15
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287523 0
Hospital
Name [1] 287523 0
Gum Bequest, Endocrine and Metabolic Unit, Royal Adelaide Hospital
Country [1] 287523 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 286268 0
None
Name [1] 286268 0
Address [1] 286268 0
Country [1] 286268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289501 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 289501 0
Ethics committee country [1] 289501 0
Australia
Date submitted for ethics approval [1] 289501 0
Approval date [1] 289501 0
30/05/2013
Ethics approval number [1] 289501 0
130229

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41102 0
A/Prof Chris Rayner
Address 41102 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 41102 0
Australia
Phone 41102 0
+61 8 82222916
Fax 41102 0
+61 8 82233870
Email 41102 0
chris.rayner@adelaide.edu.au
Contact person for public queries
Name 41103 0
Chris Rayner
Address 41103 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 41103 0
Australia
Phone 41103 0
+61 8 82222916
Fax 41103 0
+61 8 82233870
Email 41103 0
chris.rayner@adelaide.edu.au
Contact person for scientific queries
Name 41104 0
Chris Rayner
Address 41104 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 41104 0
Australia
Phone 41104 0
+61 8 82222916
Fax 41104 0
+61 8 82233870
Email 41104 0
chris.rayner@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdministration of resveratrol for 5 wk has no effect on glucagon-like peptide 1 secretion, gastric emptying, or glycemic control in type 2 diabetes: A randomized controlled trial.2016https://dx.doi.org/10.3945/ajcn.115.117440
N.B. These documents automatically identified may not have been verified by the study sponsor.