UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023051 |
|---|---|
| Receipt number | R000026527 |
| Scientific Title | The energy balance study in the elderly facility residents, COPD and diabetic patients: a comparative cross-sectional study of diabetic patients and control subjects |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2022/07/13 20:02:52 |
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Basic information
Public title
The energy balance study in the elderly facility residents, COPD and diabetic patients: a comparative cross-sectional study of diabetic patients and control subjects
Acronym
The energy balance study in diabetic patients.
Scientific Title
The energy balance study in the elderly facility residents, COPD and diabetic patients: a comparative cross-sectional study of diabetic patients and control subjects
Scientific Title:Acronym
The energy balance study in diabetic patients.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to provide the reliable data for the Dietary Reference Intakes for Japanese (2020 edition), especially by measuring energy balance in 1) frail elderly, 2) disease patients (COPD, diabetes) .
Our university aims to compare the energy requirements / expenditure between diabetic and non-diabetic patients.
Basic objectives2
Others
Basic objectives -Others
The difference of energy consumption per body weight between diabetic and non-diabetic patients, measured with the doubly labeled water method.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The difference of energy consumption per body weight between diabetic and non-diabetic patients, measured with the doubly labeled water method.
Key secondary outcomes
1. the difference between the diabetic and non-diabetic patients in total energy expenditure and basal metabolic rate per body weight by doubly labeled water method and indirectly calorimetry.
2. the difference among the diabetic treatment group in total energy expenditure and basal metabolic rate per body weight by doubly labeled water method and indirectly calorimetry.
3. the difference between the diabetic and non-diabetic patients in energy balance (dietary records - brief-type diet history questionnaire(BDHQ) - total energy consumption by doubly labeled water method)
4. the difference between the diabetic and non-diabetic patients in physical activity measured by the activity monitor.
5. the interrelationship between the diabetic and non-diabetic patients in physical activity measured by physical activity questionnaire.
6. the difference between the diabetic and non-diabetic patients in muscle mass and skeletal muscle cell volume.
7. the relationship among glucosuria, 1.5-AG and energy gap
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diabetes patient group:
1. Out patients with type 2 diabetes mellitus at Shiga University Hospital from August 2016 to May 2017
2. Aged 60 years to 79 years old
3. BMI 18 or more and less than 35
Non-diabetic patient group:
Control subjects who are normal glucose level, visiting Shiga University Hospital for dyslipidemia, hypertension, and obesity.
1. Out patients with hypertension, dyslipidemia, and obesity at Shiga University Hospital from August 2016 to May 2017
2. Age 60 years old to 79 years old
3. BMI 18 or more and less than 35
The definition of the non-diabetic group is subject without diabetic medications and without past or current history of diabetes or with HbA1c < 6.0 within one year.
Key exclusion criteria
1. drug that affects the energy balance (thyroid drugs, beta-blockers, GLP-1R agonist)
2. agents that influence to affect the metabolism of water (diuretics, SGLT2 inhibitors)
3. pregnancy, those in nursing
4. Those who surgery is scheduled
5. cancer, a patient being treated with arthritis
6. history of surgery that affect the food intake and absorption
7. persons within six months from the initial visit
8. with impaired physical activity (orthopedic disease, stroke, heart disease)
9. patients with severe diabetes complications
10. myositis, muscle disease patient, such as muscular dystrophy
11. Frequent (more than 5 days /week) muscular labor for more than one hour a day
12. Others attending physician was deemed inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Maegawa |
Organization
Shiga University of Medical Science
Division name
Division of Endocrinology and Metabolism
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
077-548-2222
maegawa@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Sasaki |
Organization
Shiga University Hospital
Division name
Clinical Nutrition
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN 520-2192
TEL
077-548-2518
Homepage URL
sasaki@belle.shiga-med.ac.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta, Tsukinowa, Otsu, 520-2192, JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.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
滋賀医科大学医学部附属病院(滋賀県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://drc.bmj.com/content/7/1/e000648
Publication of results
Published
Result
URL related to results and publications
https://drc.bmj.com/content/7/1/e000648
Number of participants that the trial has enrolled
67
Results
The mean TEE per body weight adjusted for sex and age was 36.5 kcal/kg/day and 37.5 kcal/kg/day in the DM and non-DM group, respectively, with no significant difference (mean difference, -1.0 kcal/kg/day; 95% CI -4.2 to 2.3 kcal/kg/day). The BMR tended to be higher in the DM than in the non-DM group. The mean PAL adjusted for sex and age was 1.71 and 1.81 in the DM and non-DM group, respectively, without a significant difference. TEE was comparable between Japanese patients with and without DM.
Results date posted
| 2022 | Year | 07 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria for the DM group were as follows: outpatients with type 2 DM, age 60-79 years, and BMI of 18 to <35 kg/m2. The inclusion criteria for the non-DM group were as follows: outpatients who were visiting the SUMS Hospital for dyslipidemia, hypertension, and obesity; age 60-79 years; and BMI of 18 to <35 kg/m2. The non-DM group comprised patients without diabetic medications and without past or current DM, or with an HbA1c level of <6.0% within 1 year. The numbers of patients with DM treated with insulin, oral antidiabetic drugs, and diet were 18 (34.6%), 20 (38.5%), and 14 (26.9%), respectively. The mean level of glycated hemoglobin was 6.9% and 5.5% in the DM and non-DM group, respectively (p<0.001). The mean body mass index was 23.3 and 22.7 kg/m2 in the DM and non-DM group, respectively.
Participant flow
Before enrollment, we screened 2050 outpatients to evaluate the prevalence of DM and its treatment, as well as the distribution of age, sex, BMI, and HbA1c. Of these 2050 patients, 16 and 59 patients were enrolled in the non-DM and DM groups according to the inclusion criteria explained in the Methods section. After exclusion of 1 patient from the non-DM group and 7 patients from the DM group who withdrew their consent, 15 and 52 patients were included for analysis in the non-DM and DM groups, respectively.
Adverse events
N/A
Outcome measures
Total Energy Expenditure: DLW method
Basal Metabolic Rate: indirect calorimetry
Physical Activity: triaxial accelerometer, step counts, questionary
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main observation item
The difference of energy consumption per body weight between diabetic and non-diabetic patients, measured with the doubly labeled water method.
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026527
