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

NCT04213300 | Completed

• 1 other identifier: HREC/2019/QGC/54049
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Quality of life; Glycaemic control; Low carbohydrate diet

Outcome Measures

Primary Outcomes (4)

• Self reported quality of life at 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

  % 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

  Baseline (pre intervention) in glycaemic control (HbA1c)

  Baseline (pre intervention)

• Glycaemic control (HbA1c)

  % change in glycaemic control from baseline to 12 weeks (post intervention) (HbA1c)

  12 weeks (pre and post intervention)

Study Arms (1)

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

Interventions

Low carbohydrate diet OTHER

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) .

Low carbohydrate dietary group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gold Coast Hospital and Health Service: lead
• University of Canberra: collaborator

Study Sites (1)

Gold Coast Hospital and Health Service

Gold Coast, Queensland, 4215, Australia

Location

Related Publications (1)

• Paul J, Jani R, Davoren P, Knight-Agarwal C. Association Between a Low Carbohydrate Diet, Quality of Life, and Glycemic Control in Australian Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Pilot Study. JMIR Res Protoc. 2021 Mar 26;10(3):e25085. doi: 10.2196/25085.

  PMID: 33769300 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Janine Paul, MSc

  Gold Coast Hospital and Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 30, 2019
• Study Start: January 15, 2021
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)