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Completed

NCT Number: NCT04032561

Relationship Between HbA1c Level, Sleep Quality and Sleep Duration

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Mental Disorders Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pre Diabetes Signs and Symptoms Sleep Disorder Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS/HSC Site

London, NW5 2BX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. HbA1c

    Time frame: Within 12 months

    Retrieved from NHS referral database

Sponsors and collaborators

Lead sponsor

University of Hertfordshire

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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