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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020157
Receipt No. 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

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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
Email 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
Email holy197741@me.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023286

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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