Relationship Between HbA1c Level, Sleep Quality and Sleep Duration

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032561
• Other study ID #: LMS/UG/NHS/02928
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: September 6, 2019

Study information

• Verified date: November 2020
• Source: University of Hertfordshire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Pre Diabetes
• Prediabetic State
• Sleep Disorder
• Sleep Wake Disorders

Locations

Country	Name	City	State
United Kingdom	NHS/HSC Site	London

Sponsors (1)

Lead Sponsor	Collaborator
University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	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
Primary	Sleep Duration	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	HbA1c	Retrieved from NHS referral database	Within 12 months