Relationship Between HbA1c Level, Sleep Quality and Sleep Duration

NCT04032561 | Completed

• 1 other identifier: LMS/UG/NHS/02928
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Pre Diabetes; Sleep Disorder

Keywords

HbA1c; Sleep Quality; Sleep Duration; PSQI

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• HbA1c

  Within 12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Aged 18 years - 65 years with pre-diabetes (diagnosed as HbA1c referral reading of between 42-47mmol/mol within the last 12 months)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hertfordshire: lead

Study Sites (1)

NHS/HSC Site

London, NW5 2BX, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: January 8, 2019
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

GB (1)