Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000423617
Ethics application status
Approved
Date submitted
10/04/2014
Date registered
17/04/2014
Date last updated
17/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to assess a low volume meal test and a very low calorie diet in obese patients with type 2 diabetes, for the future study of bariatric surgery.
Scientific title
A pilot study to assess a low volume meal test to assess
gut peptide physiology, and the tolerability and safety of a short term very low caloric restriction diet in obese patients
with type 2 diabetes.
Secondary ID [1] 284419 0
Nil
Universal Trial Number (UTN)
U1111­-1154­-4243
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 291619 0
Diabetes 291620 0
Condition category
Condition code
Diet and Nutrition 291996 291996 0 0
Obesity
Metabolic and Endocrine 291997 291997 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 participants will be recruited. The study comprises 2 sub studies (study 1 and study 2) and the same 12 participants will undertake both studies. For study 1, participants will be asked to attend our research centre on two separate days (within 7 days of eachother) where a liquid meal test will be performed. This involves the consumption by the participant of a liquid meal (similar to yoghurt in consistency, TWOCAL HN, Abbots nutrition, fat 39.4%, carbohydrate 43%, protein 16.8%, 2 calories/ml) within 10 minutes, and the collection of blood samples immediately before and then at 10,20,30,60,90,120,150, and 180 minutes after the drink is consumed. The volume of the liquid meal will differ between the 2 days (200ml and 50ml), and participants will be randomised as to which of the liquid meal volumes used in this study they undertake first.

Study 2 will commence immediately after completion of the second liquid meal test for study 1, and involves participants adhering to a very low calorie diet for 4 days. Participants will be asked to consume no food or drink (with the exception of water) for the 96 hour period from the consumption of the liquid meal through to 8am on study day 6. They will be asked to attend our research unit daily during this time (study days 3-6) for an assessment (including a blood test) and the intravenous administration of 2000ml of dextrose solution (providing 340 calories). At 8am on study day 6 a third liquid meal test will be performed as above before the study is completed. The volume of the meal on consumed by each participant on study day 6 will be the same as taken on study day 2. Adherence to the intervention will be monitored through a daily interview and assessment.
Intervention code [1] 289168 0
Other interventions
Comparator / control treatment
Study 1 will assess the performance of a low volume meal test against a standard volume (control). Each participant will undertake both meal tests within a 7 day period, and will thus act as their own controls.
Study 2 will assess a number of parameters (weight, blood pressure, heart rate, kidney function, etc) for each participant during the period of caloric restriction (days 3-6) and compare these against baseline results for each participant (study day 2). Each participant will thus act as their control, and each participant will receive the intervention.
Control group
Active

Outcomes
Primary outcome [1] 291889 0
Effect of low volume meal test on gut peptide physiology when compared with standard volume. Mean hormone level at each time point will be calculated along with the standard deviation and variance. 95% confidence intervals will be calculated. Mean hormone levels at time point +10 through to +180 minutes will be compared to baseline results using a paired T-test. Results will be considered statistically significant if the p value is <0.05. The area under the curve of each hormone at each time point will be calculated along with an assessment of dynamic change (delta). The standard deviation and variance of these results will be calculated, and a comparison will be made between results at the same time point after the 50 and 200ml liquid meal tests.
Timepoint [1] 291889 0
1 week (study day 2)
Primary outcome [2] 291890 0
Effect of very low calorie diet on physical examination (weight, blood pressure, heart rate)
Timepoint [2] 291890 0
5 days (study day 6)
Primary outcome [3] 291934 0
Effect of very low calorie diet on blood tests (electrolytes, renal function and hepatic function)
Timepoint [3] 291934 0
5 days (Study day 6)
Secondary outcome [1] 307748 0
Nil
Timepoint [1] 307748 0
Nil

Eligibility
Key inclusion criteria
1. BMI >35 kg/m2
2. Type 2 diabetes treated with diet or tablets (Metformin and/or a Sulphonylurea)
3. HbA1c<86 mmol/mol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes
2. Use of Insulin therapy
3. Recent significant weight change (> 5 kg over past 3 months)
4. Previous bariatric surgery
5. Currently pregnant or planning pregnancy within 3 months
6. Significant medical condition which, in the view of study investigators, would make recruitment in study inappropriate.

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)
Potential participants will be identified from diabetes clinics run at Wellington regional hospital. Information regarding the study will be provided to those who show an interest in participation. An appointment will then be made for consent to be obtained. Once this has been confirmed, participants will be randomised to one of two study arms by means of selecting a sealed envelope containing details on allocation. Randomisation will be 1:1. The 2 arms will differ with respect to which volume liquid meal they undertake at study day 1 and study day 2 (a standard or low volume meal)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sealed envelopes will be prepared in advance by an independent researcher, and both the participant and study investigator will be blinded to contents. Participants will select an envelope, thus each participant will be randomly allocated to a study arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A randomised crossover design will be utilised in this study. Two statistical analyses will be performed on study 1 data. Firstly, the mean hormone level at each time point will be calculated along with the standard deviation and variance. 95% confidence intervals will be calculated. Mean hormone levels at time point +10 through to +180 minutes will be compared to baseline results using a paired T-test. Results will be considered statistically significant if the p value is <0.05.

Secondly, the area under the curve of each hormone at each time point will be calculated along with an assessment of dynamic change (delta). The standard deviation and variance of these results will be calculated, and a comparison will be made between results at the same time point after the 50 and 200ml liquid meal tests.

For study 2, the mean of each measured parameter from study day 3 through to 6 will be compared against the respective mean from study day 2 (baseline) with the use of a paired T test. Results that fall above or below reference laboratory/clinical ranges will be noted.

There is no published data on either a low volume meal test or the degree of caloric restriction required to allow sample size calculation. The role of this pilot study is to assess these tools and allow future study (including of these interventions if required).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 5994 0
New Zealand
State/province [1] 5994 0

Funding & Sponsors
Funding source category [1] 289068 0
Other Collaborative groups
Name [1] 289068 0
Endocrine, diabetes and research centre
Wellington regional hospital
Country [1] 289068 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Endocrine, diabetes and research centre
Address
Level 5 Grace Neill block
Wellington regional hospital
Riddiford Street
Newtown
Wellington 6011
Country
New Zealand
Secondary sponsor category [1] 287731 0
None
Name [1] 287731 0
Address [1] 287731 0
Country [1] 287731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290862 0
Northern B ethics committee
Ethics committee address [1] 290862 0
Ministry of Health
C/- MEDSAFE Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290862 0
New Zealand
Date submitted for ethics approval [1] 290862 0
Approval date [1] 290862 0
07/04/2014
Ethics approval number [1] 290862 0
14/NTB/35

Summary
Brief summary
This is a study of 2 research tools, the availability of which will allow more detailed studies exploring the mechanism underlying the improvements in diabetes control seen very early after bariatric (weight loss) surgery. Participants will be asked to undergo 2 liquid meal tests to assess whether a small volume meal test performs as well as a standard volume meal test in the assessment of gut hormones. Participants will also be calorie restricted for 4 days under supervision. The degree of calorie restriction is approximately 15% of the recommended daily intake and is comparable to the intake of calories seen within the first 5 days following bariatric surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47642 0
Dr Jeremy Krebs
Address 47642 0
Endocrine, diabetes, and research centre
Level 5 Grace Neill Block
Wellington regional hospital,
Riddiford Street
Newtown
Wellington 6011
Country 47642 0
New Zealand
Phone 47642 0
+64 4 8062140
Fax 47642 0
Email 47642 0
[email protected]
Contact person for public queries
Name 47643 0
Richard Carroll
Address 47643 0
Endocrine, diabetes, and research centre
Level 5 Grace Neill Block
Wellington regional hospital,
Riddiford Street
Newtown
Wellington 6011
Country 47643 0
New Zealand
Phone 47643 0
+64 4 8062140
Fax 47643 0
Email 47643 0
[email protected]
Contact person for scientific queries
Name 47644 0
Richard Carroll
Address 47644 0
Endocrine, diabetes, and research centre
Level 5 Grace Neill Block
Wellington regional hospital,
Riddiford Street
Newtown
Wellington 6011
Country 47644 0
New Zealand
Phone 47644 0
+64 4 8062140
Fax 47644 0
Email 47644 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

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Documents added automatically
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