UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053513 |
|---|---|
| Receipt number | R000061043 |
| Scientific Title | Prospective follow-up study of the usefulness of a relatively low-carbohydrate insulin diet/high-protein, fat diet |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/05 16:14:18 |
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Basic information
Public title
The clinical usefulness of a new diet for effective weight loss and metabolic improvement in obese patients: a prospective follow-up study on the usefulness of a relative low carbohydrate and low insulin diet in patients with BMI 35 and more kg/m2.
Acronym
Clinical usefulness of a low-glycemic/low-Insulin diet for body weight reduction in morbidly obese patients
Scientific Title
Prospective follow-up study of the usefulness of a relatively low-carbohydrate insulin diet/high-protein, fat diet
Scientific Title:Acronym
Low Glycemic- and Low Insulin- Diet
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the usefulness of a low glycemic/low insulin diet as a treatment modality for weight loss and metabolic improvement in patients with BMI 30 and more kg/m2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following data will be measured. Weight loss, fasting blood glucose, HbA1c, insulin secretion (HOMA-beta), insulin resistance (HOMA-R), cardiovascular risk factors (BP, LDL-C, TG, HDL-C), visceral fat mass, fatty liver variables, TG, Apo B100, Apo B 48 values measured under a meal tolerance test, and the effects of the intervention test on dietary behavior change will be evaluated. Measurements were taken before start, and after 3, 6 and 12 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Standard low-energy diet (25 kcal/ kg standard body weight/m2)
Interventions/Control_2
Low glycemic/low insulin diet
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age: 20 to 70 years old
men and women
Patients with a BMI of 30 kg/m2 or more
T2DM patients without severe cardiovascular, hepatic or renal impairments
Key exclusion criteria
Obese type 2 diabetic patients using either insulin or GLP-1 receptor agonists at the time of entry
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Yamamoto |
Organization
Omi medical center
Division name
Diabetes and Endcrinorogy
Zip code
5258585
Address
1660 Yabase Kusatus-city Sgiga-ken
TEL
0775638866
yukako.911426@gmail.com
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Yamamoto |
Organization
Hospital
Division name
Diabetes and Endcrinorogy
Zip code
5258585
Address
1660 Yabase Kusatus-city Sgiga-ken
TEL
0775638866
Homepage URL
yukako.911426@gmail.com
Sponsor or person
Institute
Omi Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Omi Medical Center
Address
1660 Yabase Kusatus-city Sgiga-ken
Tel
0775638866
yukako.911426@gmail.com
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
| 2024 | Year | 04 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | 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 | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061043
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
