ANZCTR - Registration

Registration number

ACTRN12617001363370p

Ethics application status

Not yet submitted

Date submitted

14/09/2017

Date registered

27/09/2017

Date last updated

27/09/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

LUCI1D Study: Lowering Carbohydrate Intake in Adults with Type 1 Diabetes

Scientific title

LUCI1D Study: Effect of lowering Carbohydrate Intake on HbA1c and insulin dose requirement in Adults with Type 1 Diabetes

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1202-1675

Trial acronym

LUCI1D Study - Lowering Carbohydrate Intake in adults with type 1 Diabetes

Linked study record

Nil

Health condition

Health condition(s) or problem(s) studied:

Type 1 Diabetes Mellitus

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: Participants will receive dietary advice to actively lower average daily carbohydrate intake to less than 100g. Education will be provided by a dietitian with at least 5-years' clinical experience. The education session will be a 1-hour one-on-one session conducted in the hospital diabetes clinic, followed by two 30-minute follow-up sessions at 1 and 2 weeks post-randomization. The content will be based on the recommendations contained in the CSIRO Low Carbohydrate Diet, but adapted for use in the study by the research team. Personalized meal plans will be developed by the dietitian with each participant, including 4-6 meal options for breakfast, lunch and dinner along with options for snacks. A matching program of education regarding expected insulin dose reductions will be delivered by the Endocrinologist conducting the study. This will be provided in a 20-minute session following the dietitian education, and supported by personalized insulin dose recommendations in written format. Written information regarding lower carbohydrate diets, recipe options and guidelines for insulin dose adjustments will be provided in written and electronic format.
Close follow-up will be provided to ensure safety and support to participants, through weekly phone or email contact for the first 4 weeks, and then fortnightly. The duration of the intervention will be 3 months (post randomization).

Intervention code [1]

Treatment: Other

Comparator / control treatment

Comparator / control treatment:
The control group is a wait-list control, where participants will be advised to continue their usual diet so that their minimum daily average intake of carbohydrate is 150g for a period of 3 months following randomization. Follow-up contact will be made monthly by email or phone by the Chief Investigator or research Nurse during the 3 months.

This group receives the intervention (lower carbohydrate diet recommendations) after 3 months.

These participants will follow standard practice of carbohydrate counting and dose adjustments of Apidra according to prescribed carbohydrate ratios and correction factors. Education regarding carbohydrate counting, matching doses of Apidra for dietary carbohydrate will be provided in by the Dietitian and the Endocrinologist. This will be provided in the Run-in Phase and updated at the beginning of the 3 months for this group. This 1-hour session will be provided in the hospital diabetes clinic.

Control group

Active

Outcomes

Primary outcome [1]

Mean change in HbA1c, as measured by serum assay at 3 months

Timepoint [1]

Primary endpoints will be measured at 3 months, and compared with the baseline dataset. The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively.

Primary outcome [2]

Mean change in insulin dose requirement, assessed at 3 months. The information about insulin dose requirement will be collected as self-reported insulin doses during participant interview.

Timepoint [2]

Primary endpoints will be measured at 3 months after randomization.
The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point (following randomization) for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively.

Secondary outcome [1]

Change in parameters of glycaemic variability as calculated from continuous glucose monitoring data.
These calculations include standard deviation, Mean Amplitude of Glycaemic Excursion (MAGE), and J-index as validated methods of assessing glycaemic variability from CGM data.

Timepoint [1]

Secondary endpoints will be measured at 3 months after randomization.
The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point (following randomization) for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively.

Secondary outcome [2]

Change in the composition of colonic microbiota. Stool specimens will be analysed using 16S ribosomal RNA quantitative PCR methods to determine the predominant bacterial species.

Timepoint [2]

Secondary endpoints will be measured at 3 months after randomization.
The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point (following randomization) for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively

Secondary outcome [3]

Change in level of diabetes treatment satisfaction, using the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
At baseline, the DTSQs will be used to assess baseline level of satisfaction
At 3 months, the matching questionnaire (DTSQc) will be used to assess for change in level of treatment satisfaction.

Timepoint [3]

At 3 months after randomization.

Secondary outcome [4]

Change in mean visceral adipose tissue, as measured by DEXA scan.

Timepoint [4]

Secondary endpoints will be measured at 3 months after randomization.
The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point (following randomization) for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively

Secondary outcome [5]

Change in fasting lipid profile, Serum measures of total cholesterol, triglycerides and LDL cholesterol will be measured 3 months after randomization

Timepoint [5]

Secondary endpoints will be measured at 3 months after randomization.
The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point (following randomization) for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively

Secondary outcome [6]

Change in serum levels of inflammatory mediators, including high sensitivity CRP and free fatty acids

Timepoint [6]

Secondary endpoints will be measured at 3 months after randomization.
The control group then is exposed to the intervention for 3 months. Data will be recollected at the 6-month time point (following randomization) for both groups where the participants in the "control" group and "intervention" group will have been exposed to the intervention for 3-months and 6-months respectively

Eligibility

Key inclusion criteria

Age 18 - 80
Confirmed diagnosis of Type 1 Diabetes
Basal bolus insulin regimen

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Pregnant or breastfeeding
Recognised diagnosis of eating disorder
Malabsorption syndrome eg. coeliac disease
Stage 3-5 Chronic Kidney Disease
Unwilling to attend clinic

Study design

Statistical methods / analysis

Power calculations are based on 80% power to detect an absolute reduction in HbA1c of 0.5% at a significance level of 0.05 on a two-tailed test.
The data obtained will be analysed using descriptive statistics.
A multivariate (linear/ logistic / negative binomial) regression model will be used to identify if there are significant differences in clinical outcomes

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

12/02/2018

Actual

Date of last participant enrolment

Anticipated

27/07/2018

Actual

Date of last data collection

Anticipated

29/03/2019

Actual

Sample size

Target

40

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Toowoomba Hospital - Toowoomba

Recruitment postcode(s) [1]

4350 - Toowoomba

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Toowoomba Hospital Foundation

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Toowoomba Hospital

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Darling Downs Hospital and Health Service HREC

Ethics committee address [1]

DDHHS HREC Coordinator
Level 5 Surgical Block
Toowoomba Hospital
PMB 2
Toowoomba QLD 4350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/09/2017

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The increasing popularity of low carbohydrate diets in the community has meant that people with Type 1 Diabetes are adopting these diets, with the expectation of improved glucose control and weight loss.  
Where there is very limited research to guide this practice in people with Type 1 Diabetes, this project aims to assess whether lowering dietary carbohydrate improves glucose control and clinical outcomes for adults with Type 1 Diabetes Mellitus. 
This study is a randomized controlled study of adults with Type 1 Diabetes, that aims to compare the effect of a lower carbohydrate diet (average intake of less than 100g per day) with standard dietary recommendations (more than 150g per day) on glucose control, insulin doses, rates of hypoglycaemia, perceived quality of life and treatment satisfaction. 
We seek to explore potential mechanisms for changes in glucose control, focusing on the impact of dietary changes on the gut microbiome, intestinal epithelial permeability, body composition and inflammatory mediators.
We hypothesise that intentional lowering of dietary carbohydrate will be associated with reduced dose requirement of insulin, reduced glucose variability and rates of hypoglycaemia, improved measures of perceived quality of life and alteration of gut microbiome.  We expect to see a difference in the groups at 3 months, and will extend the intervention to 6 months to assess whether this dietary change is sustainable for people with Type 1 Diabetes. 
Participants will receive detailed education regarding carbohydrate counting, recommendations for meal plans that contain a reduced carbohydrate content and advice regarding insulin dose adjustments according to changing glucose levels.  Close follow-up will be maintained by diabetes health care professionals.
Data will be collected at baseline, 3 months and 6 months, to investigate traditional clinical outcomes - HbA1c, lipid profile, urinary protein and glucose variability as well as perceived quality of life.  The effect of the dietary change will also be assessed on the intestinal microbiome, epithelial permeability and body composition.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Sheila Cook

Address

Department of Medicine
Level 6, Emma Webb Building
Toowoomba Hospital
PMB 2 Toowoomba QLD 4350

Country

Australia

Phone

+61 7 4616 6000

Email

[email protected]

Contact person for public queries

Name

Sheila Cook

Address

Department of Medicine
Level 6 Emma Webb Building
Toowoomba Hospital
Pechey Street
Toowoomba QLD 4350

Country

Australia

Phone

+61 7 4616 6000

Email

[email protected]

Contact person for scientific queries

Name

Sheila Cook

Address

Department of Medicine
Level 6 Emma Webb Building
Toowoomba Hospital
Pechey Street
Toowoomba QLD 4350

Country

Australia

Phone

+61 7 4616 6000

Email

[email protected]

Trial Review

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