UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020157 |
|---|---|
| Receipt number | R000023286 |
| Scientific Title | Efficacy and change in taste by taking SGLT2 inhibitor in patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2018/10/08 20:17:47 |
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Basic information
Public title
Efficacy and change in taste by taking SGLT2 inhibitor in patients with type 2 diabetes
Acronym
SGLT2 inhibitor and change in taste
Scientific Title
Efficacy and change in taste by taking SGLT2 inhibitor in patients with type 2 diabetes
Scientific Title:Acronym
SGLT2 inhibitor and change in taste
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examin if the taste alternate in diabetes patients after taking SGLT2 inhibitor
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BDHQ
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes
Key exclusion criteria
Pregnant women
Women who lactaes now
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
holy197741@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Horie |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
0958197200
Homepage URL
holy197741@me.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29162514
Number of participants that the trial has enrolled
Results
AIMS:
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) cause substantially less weight loss than would be expected based on their caloric deficits, probably due to enhanced appetite regulation known as "compensatory hyperphagia," which occurs to offset the negative energy balance caused by increased glycosuria. We examined whether any specific nutrients contributed to the compensatory hyperphagia in diabetic patients taking SGLT2i.
METHODS:
Sixteen patients with type 2 diabetes were newly administered dapagliflozin 5mg daily as the experimental SGLT2i group. Sixteen age-, sex- and BMI-matched type 2 diabetes patients not receiving dapagliflozin served as controls. A brief-type self-administered diet history questionnaire (BDHQ) was undertaken just before and 3 months after study initiation to evaluate changes of energy and nutrient intakes in each group.
RESULTS:
At 3months, daily intakes of total calories and the proportions of the three major nutrients were not significantly increased in either group. However, daily sucrose intake was significantly increased after treatment versus the baseline value in the SGLT2i group (p=0.003), but not in controls. The calculated intakes of all other nutrients were not significantly changed in either group.
CONCLUSIONS:
Dapagliflozin treatment specifically increased sucrose intake, which might be an ideal target for nutritional approaches to attenuate compensatory hyperphagia.
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 05 | Day |
Other
Other related information
The complete data of the study was published on the journal of Diabetes Research and Clinical Practice as a title of "Increased sugar intake as a form of compensatory hyperphagia in patients with type 2 diabetes under dapagliflozin treatment".
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023286
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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