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15-minute Individual Consultation to Improve Blood Glucose Control in Pre-diabetes

NCT03483129 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-02-05

No results posted yet for this study

Summary

This research will assess the feasibility of conducting a randomised control trial to evaluate the effectiveness of a 15-minute one-to-one consultation to improve blood glucose control in pre-diabetes. The consultation will take the form of a 15-minute one-to-one consultation between a health-care practitioner and the patient in a primary care setting. Patients with a glycated haemoglobin (HbA1c) of between 42 and 47 mmol·mol-1 will be identified in general practise and will be eligible to participate. They will attend testing sessions at baseline (before the consultation), and at three months and six months post consultation. Body mass index (BMI), waist and hip girth, blood pressure and body composition will be recorded and blood analysed for HbA1c, cholesterol and dietary components. For a three-week period following each visit, urine will be collected, a 5-ml sample on nine occasions, and physical activity will be recorded in a sub group of participants. Urine will be analysed by flow infusion electrospray mass spectrometry (FIE-MS) to determine the metabolic content, providing an indication of the diet over the three-week sampling period. The research objectives are to assess the effectiveness of recruitment strategy and willingness of patients to engage in, and adhere to, the research process; to determine the impact of consultation on health outcome measures, including HbA1c, and to establish participant and practitioner perspectives of the consultation.

Conditions

  • Pre-Diabetes

Interventions

BEHAVIORAL

Consultation

15 minute, one to one consultation with a trained practice nurse at a GP surgery. Participants will have the opportunity to discuss pre-diabetes, the risks of developing diabetes and the steps that can be taken to improve lifestyle behaviors and reduce the risk of diabetes development.

Sponsors & Collaborators

  • Hywel Dda Health Board

    collaborator OTHER

  • Aberystwyth University

    lead OTHER

Principal Investigators

  • Rhys Thatcher, Dr · Aberystwyth University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2019-01-23
Completion
2019-01-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483129 on ClinicalTrials.gov