UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055595 |
|---|---|
| Receipt number | R000063533 |
| Scientific Title | Oral Prolonged-release Supplements Impact on Glycaemic Index, Satiety ranking in patients with Type 2 Diabetes and Role on Renal Function: A Randomized Cross-Over Trial |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2024/09/24 02:31:44 |
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Basic information
Public title
Oral Prolonged-release Supplements Impact on Glycaemic Index, Satiety ranking in patients with Type 2 Diabetes and Role on Renal Function: A Randomized Cross-Over Trial
Acronym
Supplements on glycemic index in Diabetes Mellitus and Kidney Function
Scientific Title
Oral Prolonged-release Supplements Impact on Glycaemic Index, Satiety ranking in patients with Type 2 Diabetes and Role on Renal Function: A Randomized Cross-Over Trial
Scientific Title:Acronym
Supplements on glycemic index in Diabetes Mellitus and Kidney Function
Region
| South America |
Condition
Condition
Diabetes Mellitus, Impaired Kidney Function
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized, double-blind, crossover study compared the postprandial effects of oral nutritional supplements specifically for renal patients with slow-absorbing carbohydrates versus one standard nutritional supplement and one oral nutritional supplement specific for diabetics on the glycemic index, plasma insulin levels, and subjective satiety ranking in 29 patients with type 2 diabetes (DM2).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose and insulin, glycemic index, glycemic load, and satiety variables comparing oral nutritional supplements specific for renal patients with a standard supplement and with a supplement specific for diabetics
Key secondary outcomes
Include all biochemical and anthropometric characteristics of the subjects.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dietary Supplement: Ensure Abbott Nutrition
Interventions/Control_2
Dietary Supplement: Nepro Abbott Nutrition
Interventions/Control_3
Dietary Supplement: Glucerna SR Abbott Nutrition
Interventions/Control_4
Dietary Supplement: Enterex Renal Victus USA
Interventions/Control_5
Dietary Supplement: Glycolab
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 57 | years-old | <= |
Age-upper limit
| 62 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 Diabetes
Demonstrated use of oral hypoglycemic agents (metformin), for at least two months
BMI of 18.5 kg/m2 to < 35 kg/m2
Key exclusion criteria
Type 1 Diabetes
Diabetic ketoacidosis
Congestive heart failure
Gastric, renal or hepatic diseases
Myocardial infarction
Stroke
Subjects with insulin therapy, antibiotic therapy or corticosteroids
End-stage organ failure
Individuals with organ transplantation
Coagulation or bleeding disorder
Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or HIV).
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Lisse |
| Middle name | Angarita |
| Last name | Davila |
Organization
Universidad Andres Bello
Division name
Facultad de Medicina, Escuela de Nutricion y Dietetetica
Zip code
4260000
Address
UNAB Campus Concepcion Autopista 7100 Concepcion-Talcahuano, 4260000 Chile
TEL
56944096275
lisse.angarita@unab.cl
Public contact
Name of contact person
| 1st name | Lisse |
| Middle name | Angarita |
| Last name | Davila |
Organization
Universidad Andres Bello
Division name
Facultad de Medicina, Escuela de Nutricion y Dietetetica
Zip code
4260000
Address
UNAB Campus Concepcion Autopista 7100 Concepcion-Talcahuano, 4260000 Chile
TEL
56944096275
Homepage URL
https://researchers.unab.cl/es/persons/lisse-chiquinquira-angarita-davila
lisse.angarita@unab.cl
Sponsor or person
Institute
Universidad Andres Bello
Institute
Department
Personal name
Funding Source
Organization
Universidad Andres Bello
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Chilean
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universidad Andres Bello
Address
UNAB Campus Concepcion Autopista 7100 Concepcion-Talcahuano, 4260000 Chile
Tel
56944096275
lisse.angarita@unab.cl
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Universidad Andres Bello
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
29
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 24 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063533
