Back to resultsLow Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes (HiLo12)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low carbohydrate diet
High carbohydrate diet
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes ≥3 years
- Insulin pump use ≥1 year
- HbA1c ≥53 mmol/mol (7.0%)
- BMI 20-27 kg/m2
- Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
- Willingness to use continuous glucose monitoring consistently during the intervention periods
Exclusion Criteria:
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Use of SGLT-2-inhibitors
- Use of corticosteroids during or within 30 days prior to the intervention periods
- Celiac disease
- Inflammatory bowel disease
- Macroalbuminuria
- Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
- Known or suspected alcohol or drug abuse
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Sites / Locations
- Hvidovre University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low Carbohydrate Diet
High Carbohydrate Diet
Arm Description
< 100 grams of carbohydrate per day
> 250 grams of carbohydrate per day
Outcomes
Primary Outcome Measures
Percentage of Time Spent in Euglycemia
Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring
Secondary Outcome Measures
Mean Glucose
Mean glucose value assessed by continuous glucose monitoring
Standard Deviation of Glucose
Standard deviation of glucose values assessed by continuous glucose monitoring
Coefficient of Variation of Glucose
Coefficient of variation of glucose values assessed by continuous glucose monitoring
Mean Amplitude of Glycemic Excursions
Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring
Time Spent in Hypoglycemia
Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring
Time Spent in Hyperglycemia
Time spent with glucose values > 10.0 mmol/l assessed by continuous glucose monitoring
Change in A1c
Change in hemoglobin A1c
AUC Low
Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring
AUC High
Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring
Post Breakfast Glucose Excursion
Difference in post breakfast glucose excursion assessed by continuous glucose monitoring
Severe Hypoglycemia
Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)
Total Daily Dose
Total daily insulin dose
Total Daily Basal Insulin 24 Hour
Total daily basal insulin dose in the time range 00:00-24:00
Total Nightime Basal Insulin
Total nighttime basal insulin in the time range 00:00-06:00
Total Daytime Basal Insulin
Total daytime basal insulin in the time range 06:00-24:00
Total Daily Bolus Insulin
Difference in total daily bolus insulin
Blood Glucose Readings
Number of blood glucose readings
Carbohydrate Servings
Number of daily carbohydrate servings (one serving ≥ 15 grams)
Body Composition
Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry
Weight
Change in weight
Hip Circumference
Change in hip circumference
Waist Circumference
Change in waist circumference
Systolic Blood Pressure
Change in systolic blood pressure
Diastolic Blood Pressure
Change in diastolic blood pressure
Heart Rate
Change in heart rate
Diabetes Treatment Satisfaction
Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.
Hypoglycemia Fear
Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.
Cholesterol
Change in total cholesterol
HDL
Change in HDL
LDL
Change in LDL
Triglycerides
Change in triglycerides
Free Fatty Acids
Change in free fatty acids
Sodium
Change in sodium
Potassium
Change in potassium
Creatinine
Change in creatinine
Urate
Change in urate
Albumin
Change in albumin
Hemoglobin
Change in hemoglobin
Leucocytes
Change in leucocytes
Thrombocytes
Change in thrombocytes
Iron
Change in iron
Transferrin
Change in transferrin
Ferritin
Change in ferritin
Folate
Change in folate
Vitamin B-12
Change in vitamin B-12
Magnesium
Change in magnesium
Zinc
Change in zinc
U-alb-crea Ratio
Change in urine albumin-creatinine ratio
Supar
Change in Supar
CRP
Change in CRP
IL-1
Change in IL-1
IL-6
Change in IL-6
IL-8
Change in IL-8
TNF-alpha
Change in TNF-alpha
Full Information
NCT ID
NCT02888691
First Posted
August 30, 2016
Last Updated
February 28, 2023
Sponsor
Hvidovre University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02888691
Brief Title
Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes
Acronym
HiLo12
Official Title
Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Carbohydrate Diet
Arm Type
Experimental
Arm Description
< 100 grams of carbohydrate per day
Arm Title
High Carbohydrate Diet
Arm Type
Experimental
Arm Description
> 250 grams of carbohydrate per day
Intervention Type
Other
Intervention Name(s)
Low carbohydrate diet
Intervention Type
Other
Intervention Name(s)
High carbohydrate diet
Primary Outcome Measure Information:
Title
Percentage of Time Spent in Euglycemia
Description
Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Secondary Outcome Measure Information:
Title
Mean Glucose
Description
Mean glucose value assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Standard Deviation of Glucose
Description
Standard deviation of glucose values assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Coefficient of Variation of Glucose
Description
Coefficient of variation of glucose values assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Mean Amplitude of Glycemic Excursions
Description
Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Time Spent in Hypoglycemia
Description
Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Time Spent in Hyperglycemia
Description
Time spent with glucose values > 10.0 mmol/l assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Change in A1c
Description
Change in hemoglobin A1c
Time Frame
From baseline to 12 weeks
Title
AUC Low
Description
Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
AUC High
Description
Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Post Breakfast Glucose Excursion
Description
Difference in post breakfast glucose excursion assessed by continuous glucose monitoring
Time Frame
12 weeks - from baseline to end of study
Title
Severe Hypoglycemia
Description
Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)
Time Frame
From baseline to 12 weeks
Title
Total Daily Dose
Description
Total daily insulin dose
Time Frame
12 weeks - from baseline to end of study
Title
Total Daily Basal Insulin 24 Hour
Description
Total daily basal insulin dose in the time range 00:00-24:00
Time Frame
12 weeks - from baseline to end of study
Title
Total Nightime Basal Insulin
Description
Total nighttime basal insulin in the time range 00:00-06:00
Time Frame
From baseline to 12 weeks
Title
Total Daytime Basal Insulin
Description
Total daytime basal insulin in the time range 06:00-24:00
Time Frame
12 weeks - from baseline to end of study
Title
Total Daily Bolus Insulin
Description
Difference in total daily bolus insulin
Time Frame
12 weeks - from baseline to end of study
Title
Blood Glucose Readings
Description
Number of blood glucose readings
Time Frame
12 weeks - from baseline to end of study
Title
Carbohydrate Servings
Description
Number of daily carbohydrate servings (one serving ≥ 15 grams)
Time Frame
12 weeks - from baseline to end of study
Title
Body Composition
Description
Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry
Time Frame
12 weeks - from baseline to end of study
Title
Weight
Description
Change in weight
Time Frame
12 weeks - from baseline to end of study
Title
Hip Circumference
Description
Change in hip circumference
Time Frame
12 weeks - from baseline to end of study
Title
Waist Circumference
Description
Change in waist circumference
Time Frame
From baseline to 12 weeks
Title
Systolic Blood Pressure
Description
Change in systolic blood pressure
Time Frame
12 weeks - from baseline to end of study
Title
Diastolic Blood Pressure
Description
Change in diastolic blood pressure
Time Frame
12 weeks - from baseline to end of study
Title
Heart Rate
Description
Change in heart rate
Time Frame
12 weeks - from baseline to end of study
Title
Diabetes Treatment Satisfaction
Description
Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.
Time Frame
12 weeks - from baseline to end of study
Title
Hypoglycemia Fear
Description
Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.
Time Frame
12 weeks - from baseline to end of study
Title
Cholesterol
Description
Change in total cholesterol
Time Frame
12 weeks - from baseline to end of study
Title
HDL
Description
Change in HDL
Time Frame
12 weeks - from baseline to end of study
Title
LDL
Description
Change in LDL
Time Frame
12 weeks - from baseline to end of study
Title
Triglycerides
Description
Change in triglycerides
Time Frame
12 weeks - from baseline to end of study
Title
Free Fatty Acids
Description
Change in free fatty acids
Time Frame
12 weeks - from baseline to end of study
Title
Sodium
Description
Change in sodium
Time Frame
12 weeks - from baseline to end of study
Title
Potassium
Description
Change in potassium
Time Frame
12 weeks - from baseline to end of study
Title
Creatinine
Description
Change in creatinine
Time Frame
12 weeks - from baseline to end of study
Title
Urate
Description
Change in urate
Time Frame
12 weeks - from baseline to end of study
Title
Albumin
Description
Change in albumin
Time Frame
12 weeks - from baseline to end of study
Title
Hemoglobin
Description
Change in hemoglobin
Time Frame
12 weeks - from baseline to end of study
Title
Leucocytes
Description
Change in leucocytes
Time Frame
12 weeks - from baseline to end of study
Title
Thrombocytes
Description
Change in thrombocytes
Time Frame
12 weeks - from baseline to end of study
Title
Iron
Description
Change in iron
Time Frame
12 weeks - from baseline to end of study
Title
Transferrin
Description
Change in transferrin
Time Frame
12 weeks - from baseline to end of study
Title
Ferritin
Description
Change in ferritin
Time Frame
12 weeks - from baseline to end of study
Title
Folate
Description
Change in folate
Time Frame
12 weeks - from baseline to end of study
Title
Vitamin B-12
Description
Change in vitamin B-12
Time Frame
12 weeks - from baseline to end of study
Title
Magnesium
Description
Change in magnesium
Time Frame
12 weeks - from baseline to end of study
Title
Zinc
Description
Change in zinc
Time Frame
12 weeks - from baseline to end of study
Title
U-alb-crea Ratio
Description
Change in urine albumin-creatinine ratio
Time Frame
12 weeks - from baseline to end of study
Title
Supar
Description
Change in Supar
Time Frame
12 weeks - from baseline to end of study
Title
CRP
Description
Change in CRP
Time Frame
12 weeks - from baseline to end of study
Title
IL-1
Description
Change in IL-1
Time Frame
12 weeks - from baseline to end of study
Title
IL-6
Description
Change in IL-6
Time Frame
12 weeks - from baseline to end of study
Title
IL-8
Description
Change in IL-8
Time Frame
12 weeks - from baseline to end of study
Title
TNF-alpha
Description
Change in TNF-alpha
Time Frame
12 weeks - from baseline to end of study
Other Pre-specified Outcome Measures:
Title
Carbohydrate Intake
Description
Daily carbohydrate intake assessed by insulin pump download
Time Frame
12 weeks - from baseline to end of study
Title
Ketones
Description
Morning blood ketone values obtained 7 times during the study period. A single value was calculated for each study participant based on an average of the 7 datapoints.
Time Frame
Spot test at week 0, 2, 4, 6, 8, 10 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes ≥3 years
Insulin pump use ≥1 year
HbA1c ≥53 mmol/mol (7.0%)
BMI 20-27 kg/m2
Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
Willingness to use continuous glucose monitoring consistently during the intervention periods
Exclusion Criteria:
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
Use of SGLT-2-inhibitors
Use of corticosteroids during or within 30 days prior to the intervention periods
Celiac disease
Inflammatory bowel disease
Macroalbuminuria
Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
Known or suspected alcohol or drug abuse
Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30924570
Citation
Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21.
Results Reference
result
PubMed Identifier
33855222
Citation
Ji L, Li L, Ma J, Li X, Li D, Meng B, Lu W, Sun J, Liu Y, Takayanagi G, Wang Y. Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study. Endocrinol Diabetes Metab. 2021 Jan 20;4(2):e00222. doi: 10.1002/edm2.222. eCollection 2021 Apr.
Results Reference
derived
PubMed Identifier
33855215
Citation
Al-Sari N, Schmidt S, Suvitaival T, Kim M, Trost K, Ranjan AG, Christensen MB, Overgaard AJ, Pociot F, Norgaard K, Legido-Quigley C. Changes in the lipidome in type 1 diabetes following low carbohydrate diet: Post-hoc analysis of a randomized crossover trial. Endocrinol Diabetes Metab. 2021 Jan 4;4(2):e00213. doi: 10.1002/edm2.213. eCollection 2021 Apr.
Results Reference
derived
Learn more about this trial
Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes
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