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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02501343




Registration number
NCT02501343
Ethics application status
Date submitted
13/07/2015
Date registered
17/07/2015
Date last updated
7/03/2017

Titles & IDs
Public title
Alkaline Diet for Insulin Sensitivity
Scientific title
Alkaline Diet for Insulin Sensitivity
Secondary ID [1] 0 0
ADIS (SVH 14/157)
Universal Trial Number (UTN)
Trial acronym
ADIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysglycemia 0 0
Type 2 Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sodium Bicarbonate Oral Capsule
Treatment: Drugs - Placebo

Experimental: Sodium bicarbonate - High acid load meal (Western style meal) with Sodium bicarbonate (Sodibic 840mg\*2)

Placebo comparator: Placebo - High acid load meal (Western style meal) with sodibic-matching placebo


Treatment: Drugs: Sodium Bicarbonate Oral Capsule
Sodium bicarbonate 1680 mg will be administered prior to the meal

Treatment: Drugs: Placebo
Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in venous blood pH
Timepoint [1] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [1] 0 0
Changes in glycemic response to the meal
Timepoint [1] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [2] 0 0
Changes in insulin response to the meal
Timepoint [2] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [3] 0 0
Changes in arterial stiffness
Timepoint [3] 0 0
Baseline (fasting) and 3 hours post meal
Secondary outcome [4] 0 0
Changes in hunger and satiety scores
Timepoint [4] 0 0
Baseline (fasting) and 3 hours post meal

Eligibility
Key inclusion criteria
* Age range: 22-65
* Disease status: Healthy.
* Laboratory parameters: Fasting plasma glucose <7 mmol/L, HbA1c <6.5% (48 mmol/mol).
* Willingness to give written informed consent and willingness to participate and comply with the study.
Minimum age
22 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Individuals with a personal history of diabetes, hypertension, cardiovascular disease, kidney disease, respiratory disease or inflammatory disease.
* Individuals treated with medications known to affect insulin sensitivity.
* Individuals with fasting plasma glucose =7 mmol/L, HbA1c =6.5% (48 mmol/mol).
* Individuals with an unstable body weight in the past 3 months (+/- 2 kg or more).
* Individuals with a history of a psychological illness or condition that may interfere with the participant's ability to understand the requirements of the study.
* Individuals who smoke.
* Individuals who consume more than 40 g of alcohol daily.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute of Medical Research - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Dorit Samocha-Bonet, BSc(Hons) MSc(Hons) PhD
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02501343