UMIN-CTR Clinical Trial

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

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

maegawa@belle.shiga-med.ac.jp

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

Email

sasaki@belle.shiga-med.ac.jp

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Shiga University of Medical Science

Address

Seta, Tsukinowa, Otsu, 520-2192, JAPAN

Tel

077-548-3576

Email

hqrec@belle.shiga-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

滋賀医科大学医学部附属病院(滋賀県)

Date of disclosure of the study information

2016

Year

08

Month

01

Day

URL releasing protocol

https://drc.bmj.com/content/7/1/e000648

Publication of results

Published

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

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 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.

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