- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04032561
Relationship Between HbA1c Level, Sleep Quality and Sleep Duration
The Relationship Between the Elevation of Haemoglobin A1c Level, Sleep Quality and Sleep Duration in Clinically Diagnosed Pre-diabetic Patients in a Nationally Representative Sample
The study will be conducted during the period of, January 2019 - August 2019 with pre-diabetic participants on a NHS England funded National Diabetes Prevention Program (NDPP) with a clinically diagnosed Haemoglobin A1c (HbA1c) referral reading of between 42mmol/mol - 47mmol/mol within the last 12 months. The term pre-diabetic can all be used to explain blood glucose levels that are higher than normal, but not high enough for participants to be diagnosed with Type 2 diabetes. Having high blood glucose levels can increase a participant's risk of developing Type 2 diabetes and other health complications, although this is not inevitable.
100 participants will take part in the study. Participants will be eligible if they are aged between 18 and 65 years and have an HbA1c referral reading of between 42-47mmol/mol within the last 12 months.
The participants will be given a written consent form to sign to take part in the study, after receiving both written and verbal information beforehand on the study protocol from the researcher. Health screening to determine eligibility for the NHS funded program will be undertaken directly by the intervention provider.
Study design and procedures:
The study will be delivered in a controlled format and will be designed to assess the relationship between the elevation of HbA1c level, sleep quality and sleep duration in clinically diagnosed pre-diabetic participants referred and registered to join the NHS NDPP. Participants will receive a pre-program information pack in conjunction with a sleep quality and sleep duration questionnaire at the end of their 1:1 initial appointments for the NHS NDPP.
Participants will be given prepaid envelopes to send their anonymised questionnaires back to the researcher once completed after their appointments. The researcher will ensure confidentiality by keeping all questionnaires in a securely combination coded locked cupboard that only the researcher has access to. Participants will be instructed to not write their names on the questionnaires but to only state their gender, age, and referral HbA1c reading received from the relevant health care professional.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, NW5 2BX
- NHS/HSC Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participants were eligible if they were aged 18 years - 65 years
- Had an HbA1c referral reading of between 42-47mmol/mol within the last 12 months
- Registered on the NHSE NDPP
Exclusion Criteria:
- Participants with a severe debilitating disease which may have interfered with the study participation
- Under the age of 18 years or over the age of 65 years
- Pregnant
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality
Time Frame: 1 month
|
Sleep quality was measured from PSQI. Scoring system: Not during the past month = 0 Less than once a week = 1 Once or twice a week = 2 Three or more times a week = 3 |
1 month
|
Sleep Duration
Time Frame: 1 month
|
Sleep duration was measured from PQSI. Scoring system: Not during the past month = 0 Less than once a week = 1 Once or twice a week = 2 Three or more times a week = 3 |
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: Within 12 months
|
Retrieved from NHS referral database
|
Within 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMS/UG/NHS/02928
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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