| Trial ID: | L6030 |
| Source ID: | NCT02501343
|
| Associated Drug: |
Sodium Bicarbonate Oral Capsule
|
| Title: |
Alkaline Diet for Insulin Sensitivity
|
| Acronym: |
ADIS
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Dysglycemia|Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Sodium Bicarbonate Oral Capsule|DRUG: Placebo
|
| Outcome Measures: |
Primary: Changes in venous blood pH, The investigators aim is to determine whether venous blood pH decreases after a high acid load meal, and whether this effect is attenuated by administration of sodium bicarbonate prior to a mixed meal study, Baseline (fasting) and 3 hours post meal | Secondary: Changes in glycemic response to the meal, Postprandial glucose excursion will be compared between sodium bicarbonate and placebo, Baseline (fasting) and 3 hours post meal|Changes in insulin response to the meal, Postprandial insulin excursion will be compared between sodium bicarbonate and placebo, Baseline (fasting) and 3 hours post meal|Changes in arterial stiffness, Postprandial arterial stiffness (measured by the augmentation index derived from Sphygmocore, Atcor Medical, Australia) will be compared between sodium bicarbonate and placebo, Baseline (fasting) and 3 hours post meal|Changes in hunger and satiety scores, Postprandial hunger and satiety will be compared between sodium bicarbonate and placebo, Baseline (fasting) and 3 hours post meal
|
| Sponsor/Collaborators: |
Sponsor: Garvan Institute of Medical Research
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
32
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2015-03
|
| Completion Date: |
2016-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-03-07
|
| Locations: |
Garvan Institute of Medical Research, Darlinghurst, New South Wales, 2010, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT02501343
|
