Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults With Type 1 Diabetes

November 19, 2021 updated by: Gold Coast Hospital and Health Service

The Association Between a Low Carbohydrate Diet, Glycaemic Control and Quality of Life in Australian Adults Living With Type 1 Diabetes Mellitus: A Pilot Study

The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in Australian adults with T1DM. The first phase of the study will develop and validate a diabetes specific quality of life questionnaire for adults with T1DM. The second phase will undertake a low carbohydrate diet intervention and examine its association with quality of life and glycaemic control, pre and post the dietary intervention. The novel outcomes will include a new validated Australian T1DM specific quality of life questionnaire and an investigation as to whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in Australian adults with T1DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 1:

Aim: To develop a reliable and valid diabetes specific quality of life questionnaire for use in Australian adults living with type 1 diabetes mellitus (T1DM).

Objectives:

  1. To develop a new Australian diabetes specific quality of life online questionnaire integrating participant feedback using a one to one interview method;
  2. Pilot the study developed online questionnaire with adults that have type 1 diabetes mellitus and
  3. Conduct factorial validation of the study developed online questionnaire using advanced statistical modelling techniques.

Phase 2:

Aim: The aim of this study is to examine the association between a low carbohydrate diet, quality of life and glycaemic control in adults living with T1DM.

Objectives:

  1. To examine the association between quality of life and glycaemic control in adults with T1DM;
  2. Implement a low carbohydrate diet in a cohort of adults living with T1DM;
  3. Examine the association between a low carbohydrate diet and glycaemic control in adults with T1DM: pre and post intervention;
  4. Examine the association between quality of life and a low carbohydrate in adults with T1DM: pre and post intervention and
  5. Investigate whether a low carbohydrate diet mediates the relationship between quality of life and glycaemic control in adults with T1DM.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Gold Coast, Queensland, Australia, 4215
        • Gold Coast Hospital and Health Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • Male, female or unspecified gender;
  • 18 years of age or over;
  • Type 1 diabetes for ≥1 year from diagnosis date and
  • Individuals who administer insulin using multiple daily injections.

Description

Inclusion Criteria:

  • Male, female or unspecified gender;
  • 18 years of age or over;
  • Type 1 diabetes for ≥1 year from diagnosis date and
  • Individuals who administer insulin using multiple daily injections.

Exclusion Criteria:

  • Patients with type 2 diabetes mellitus;
  • Patients with gestational diabetes mellitus;
  • Presence of a known food allergy or intolerance that may affect the participants' health or adherence during the intervention;
  • History of an eating disorder;
  • BMI <25.0kg/m2 to 29.9kg/m2;
  • Age <18 years;
  • An active medical problem that may hinder the persons' ability to take part or potentially affect study outcomes e.g. a recent myocardial infarction, stroke or peripheral revascularisation (within 3 months), active treatment of diabetic retinopathy, recent serious infection (requiring in-hospital treatment or prolonged antibiotic therapy), active mental health complaint or other active medical problems determined by medical staff;
  • Pregnancy or expectation of conceiving. Participants will be withdrawn at any stage from the study if pregnancy occurs;
  • The use of medications that may affect body weight/body composition (including but not limited to phentermine and corticosteroids);
  • Those for whom the written materials may be unsuitable such as vision impaired or illiterate individuals;
  • Those unable to understand English;
  • Those who failed to provide informed consent and
  • Those who administer insulin using a continuous subcutaneous insulin infusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low carbohydrate dietary group

Participants n = 23

Participants:

  • Male, female or unspecified gender;
  • 18 years of age or over;
  • Type 1 diabetes for ≥1 year from diagnosis date and
  • Individuals who administer insulin using multiple daily injections.
Other: Low carbohydrate diet

Study duration: 13 weeks (run in phase = 1 week; low carbohydrate diet phase = 12 weeks).

Each participant will be provided with an individualised meal plans to meet their energy needs as per the Schofield formula and a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat.

Participants will self-report quality of life using a validated diabetes specific quality of life questionnaire for Australian adults and HbA1c (pre and post intervention phase of 13 weeks duration) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported quality of life at baseline pre intervention
Time Frame: Baseline (pre intervention)
Baseline (pre intervention) participant self reported quality of life using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention
Baseline (pre intervention)
Self reported quality of life at 12 weeks post intervention
Time Frame: 12 weeks (post intervention)
% change in participant self reported quality of life from baseline to 12 weeks (post intervention) using the newly validated Australian diabetes specific quality of life questionnaire which uses a Likert scale of 1 = very strongly disagree to 10 = very strongly agree, from baseline to 12 weeks after intervention
12 weeks (post intervention)
Glycaemic control (HbA1c) at baseline pre intervention
Time Frame: Baseline (pre intervention)
Baseline (pre intervention) in glycaemic control (HbA1c)
Baseline (pre intervention)
Glycaemic control (HbA1c)
Time Frame: 12 weeks (pre and post intervention)
% change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c)
12 weeks (pre and post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gold Coast Hospital and Health Service

Collaborators

University of Canberra

Investigators

  • Principal Investigator: Janine Paul, MSc, Gold Coast Hospital and Health Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

November 19, 2021

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

December 26, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/2019/QGC/54049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data collected in this study is specific to this doctoral research project. Therefore, there will be no data sharing with any other researchers who are not members of this study. Where a current research team member wishes to use any of this data research purposes, the research must be approved by an Ethics committee, involve the PI who will ultimately retain oversight of all future uses of data and will remain the ongoing custody of data and/or research outputs.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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