UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022910 |
|---|---|
| Receipt number | R000026358 |
| Scientific Title | Evaluation of the efficacy of dietary carbohydrate restriction intervention in patients with type 2 diabetes. |
| Date of disclosure of the study information | 2016/06/28 |
| Last modified on | 2023/07/04 10:04:40 |
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Basic information
Public title
Evaluation of the efficacy of dietary carbohydrate restriction intervention in patients with type 2 diabetes.
Acronym
Evaluation of the efficacy of dietary carbohydrate restriction intervention in patients with type 2 diabetes.
Scientific Title
Evaluation of the efficacy of dietary carbohydrate restriction intervention in patients with type 2 diabetes.
Scientific Title:Acronym
Evaluation of the efficacy of dietary carbohydrate restriction intervention in patients with type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether moderately low-carbohydrate diet is sustainable, we enrolled 200 type 2 diabetic patients with this diet sequentially and observed for 24 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We compered the values of HbA1c, at the first nutritional intervention and every 6-month intervals post-intervention.
Key secondary outcomes
We compared body weight, lipid profile (TC, LDL-C, HDL-C, TG), blood pressure (SBP, DBP), liver enzyme (AST, ALT), and renal function (UN, Cr, eGFR), and dietary intake date.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We compered the test values, at the first nutritional intervention and every 6-month intervals post-intervention during 96 months.
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
Diabetic patients who have a carbohydrate restriction intervention with type 2 diabetes receiving outpatient treatment in our hospital during 96 months between August 2009 and October 2022.
Key exclusion criteria
Patients with diabetic nephropathy more than 4 and during pregnancy and children were excluded from this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Yamada |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Diabetes Center
Zip code
108-8642
Address
5-9-1 Shirokane,Minato-ku,Tokyo,Japan
TEL
03-3444-6161
yamada-s@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Yamada |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Diabetes Center
Zip code
108-8642
Address
5-9-1 Shirokane,Minato-ku,Tokyo,Japan
TEL
03-3444-6161
Homepage URL
yamada-s@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional review board of Kitasato University Kitasato Institute Hospital
Address
5-9-1 Shirokane,Minato-ku,Tokyo,Japan
Tel
03-3444-6161
kenkyu@insti.kitasato-u.ac.jp
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
| 2016 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/10/5/528
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/10/5/528
Number of participants that the trial has enrolled
200
Results
Over 36 months, the mLCD intervention showed sustained effectiveness (without safety concerns) in improving HbA1c, lipid profile, and liver enzymes in Japanese patients with type 2 diabetes.
Results date posted
| 2023 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively enrolled 200 patients with type 2 diabetes who received outpatient treatment at Kitasato Institute Hospital, Tokyo, Japan between August 2009 and October 2013.
Female/Male 71/129
Age 59.7
BMI (kg/m2) 26.4
FPG (mg/dL) 151
HbA1c (%) 8.0
TG (mg/dL) 147
LDL-C (mg/dL) 116
HDL-C (mg/dL) 60
BP (mmHg) 128/76
Participant flow
The characteristics of the 200 patients enrolled. Of these, 43 participants were lost to follow-up during the 36-month study period. The most common reasons for drop-out were a discontinuation of visits to our hospital (n = 24) and referral to general physicians (n = 15). The other four participants lost to follow-up died (two from myocardial infarction, one from cardiac arrest, and one from a head injury). There were no differences in the baseline characteristics between the 43 patients who dropped out and the remaining 157.
Adverse events
No answer.
Outcome measures
At the first nutritional intervention and at six-month intervals thereafter, we measured the following: glycated hemoglobin (HbA1c), body weight, lipid profile (total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG)), blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)), liver enzymes (aspartate aminotransferase (AST), alanine aminotransferase (ALT)), and renal function (urea nitrogen (UN), uric acid (UA), creatinine (Cr), estimated glomerular filtration rate (eGFR)). We also recorded the incidence of hypoglycemia (defined as self-monitored blood glucose levels less than 70 mg/dL, with or without hypoglycemic symptoms) for 2 months before the first intervention and for 2-month intervals during the intervention, and calculated the corresponding before/after ratios. Missing values were replaced with values obtained during the previous or following two months.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026358
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