UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051181 |
|---|---|
| Receipt number | R000058374 |
| Scientific Title | The potential impact of habitual sleep quality and glycemic control status: a study based on geriatric patients recently diagnosed with type 2 diabetes mellitus in Pakistan |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/05/29 04:26:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The potential impact of habitual sleep quality and glycemic control status
Acronym
PIHSQLGC
Scientific Title
The potential impact of habitual sleep quality and glycemic control status: a study based on geriatric patients recently diagnosed with type 2 diabetes mellitus in Pakistan
Scientific Title:Acronym
PIHSQLGC
Region
| Asia(except Japan) |
Condition
Condition
Excessively short sleep durations are associated with type 2 diabetes, but there is limited information about the association between sleep quality and the development of diabetes. The present study aimed to investigate the length of sleep on the development of Type 2 diabetes mellitus.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Excessively short sleep durations are associated with type 2 diabetes, but there is limited information about the association between sleep quality and the development of diabetes. The present study aimed to investigate the length of sleep on the development of Type 2 diabetes mellitus.
Basic objectives2
Others
Basic objectives -Others
The present study aimed to investigate the length of sleep on the development of Type 2 diabetes mellitus.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The present study aimed to investigate the length of sleep on the development of Type 2 diabetes mellitus.
Key secondary outcomes
Quality and duration of sleep on the development of Type 2 diabetes mellitus.
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
| 55 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals above the age of 55 and up to (including) age 80 with newly diagnosed Type 2 diabetes mellitus in previous 12 months prior to study. Medications including metformin only.
Key exclusion criteria
1) Individuals with a history of diabetic ketoacidosis or coma in the previous 12 months
2) Individuals with prior history of surgical procedure or scheduled for surgical procedure 12 months prior and 12 months after
3) Individuals with co-morbidities such as malignancy, severe infections or trauma
4) Presence of nephropathy or liver failure
5) Any medications taken besides Metformin
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Nadia |
| Middle name | |
| Last name | Hussain |
Organization
Al Ain University
Division name
Al Ain Campus
Zip code
64141
Address
Jimi area
TEL
0505440152
nadia.hussain@aau.ac.ae
Public contact
Name of contact person
| 1st name | Saima |
| Middle name | |
| Last name | Abbass |
Organization
Shifa Hospital
Division name
Sheikhupura
Zip code
39630
Address
Nankana road
TEL
923245065017
Homepage URL
saimaabasstahammal@gmail.com
Sponsor or person
Institute
Shifa Group of Hospitals
Institute
Department
Personal name
Funding Source
Organization
Shifa Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Pakistan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shifa Hospital
Address
Sheikhupura
Tel
92 324 5065017
saimaabasstahammal@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
SH-34987345
Org. issuing International ID_1
SH-34987345
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Shifa Hospital (Lahore, Pakistan)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | 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
95
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
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study to assess impact of sleep on the development of type 2 diabetes mellitus
Management information
Registered date
| 2023 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058374
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
