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
Level 3, Hanson Institute Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
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
Resveratrol, which is a nutritional supplement derived from certain plant foods including red grapes, has the potential to improve blood sugar levels in patients with type 2 diabetes by uncertain mechanisms. In this study, we aim to identify the effects of resveratrol on the rate of gastric emptying, blood sugar levels and blood levels of hormones produced by the intestines
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
[email protected]
Contact person for public queries
Name 41103 0
A/Prof 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
[email protected]
Contact person for scientific queries
Name 41104 0
A/Prof 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
[email protected]

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.