Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— HiLo12  

Official title:

Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888691
• Other study ID #: HiLo12
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2023
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Low carbohydrate diet

• High carbohydrate diet

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Carbohydrate Intake	Daily carbohydrate intake assessed by insulin pump download	12 weeks - from baseline to end of study
Other	Ketones	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.	Spot test at week 0, 2, 4, 6, 8, 10 and 12
Primary	Percentage of Time Spent in Euglycemia	Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Mean Glucose	Mean glucose value assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Standard Deviation of Glucose	Standard deviation of glucose values assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Coefficient of Variation of Glucose	Coefficient of variation of glucose values assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Mean Amplitude of Glycemic Excursions	Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Time Spent in Hypoglycemia	Percentage of time spent with glucose values = 3.9 mmol/l assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Time Spent in Hyperglycemia	Time spent with glucose values > 10.0 mmol/l assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Change in A1c	Change in hemoglobin A1c	From baseline to 12 weeks
Secondary	AUC Low	Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	AUC High	Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Post Breakfast Glucose Excursion	Difference in post breakfast glucose excursion assessed by continuous glucose monitoring	12 weeks - from baseline to end of study
Secondary	Severe Hypoglycemia	Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)	From baseline to 12 weeks
Secondary	Total Daily Dose	Total daily insulin dose	12 weeks - from baseline to end of study
Secondary	Total Daily Basal Insulin 24 Hour	Total daily basal insulin dose in the time range 00:00-24:00	12 weeks - from baseline to end of study
Secondary	Total Nightime Basal Insulin	Total nighttime basal insulin in the time range 00:00-06:00	From baseline to 12 weeks
Secondary	Total Daytime Basal Insulin	Total daytime basal insulin in the time range 06:00-24:00	12 weeks - from baseline to end of study
Secondary	Total Daily Bolus Insulin	Difference in total daily bolus insulin	12 weeks - from baseline to end of study
Secondary	Blood Glucose Readings	Number of blood glucose readings	12 weeks - from baseline to end of study
Secondary	Carbohydrate Servings	Number of daily carbohydrate servings (one serving = 15 grams)	12 weeks - from baseline to end of study
Secondary	Body Composition	Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry	12 weeks - from baseline to end of study
Secondary	Weight	Change in weight	12 weeks - from baseline to end of study
Secondary	Hip Circumference	Change in hip circumference	12 weeks - from baseline to end of study
Secondary	Waist Circumference	Change in waist circumference	From baseline to 12 weeks
Secondary	Systolic Blood Pressure	Change in systolic blood pressure	12 weeks - from baseline to end of study
Secondary	Diastolic Blood Pressure	Change in diastolic blood pressure	12 weeks - from baseline to end of study
Secondary	Heart Rate	Change in heart rate	12 weeks - from baseline to end of study
Secondary	Diabetes Treatment Satisfaction	Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.	12 weeks - from baseline to end of study
Secondary	Hypoglycemia Fear	Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.	12 weeks - from baseline to end of study
Secondary	Cholesterol	Change in total cholesterol	12 weeks - from baseline to end of study
Secondary	HDL	Change in HDL	12 weeks - from baseline to end of study
Secondary	LDL	Change in LDL	12 weeks - from baseline to end of study
Secondary	Triglycerides	Change in triglycerides	12 weeks - from baseline to end of study
Secondary	Free Fatty Acids	Change in free fatty acids	12 weeks - from baseline to end of study
Secondary	Sodium	Change in sodium	12 weeks - from baseline to end of study
Secondary	Potassium	Change in potassium	12 weeks - from baseline to end of study
Secondary	Creatinine	Change in creatinine	12 weeks - from baseline to end of study
Secondary	Urate	Change in urate	12 weeks - from baseline to end of study
Secondary	Albumin	Change in albumin	12 weeks - from baseline to end of study
Secondary	Hemoglobin	Change in hemoglobin	12 weeks - from baseline to end of study
Secondary	Leucocytes	Change in leucocytes	12 weeks - from baseline to end of study
Secondary	Thrombocytes	Change in thrombocytes	12 weeks - from baseline to end of study
Secondary	Iron	Change in iron	12 weeks - from baseline to end of study
Secondary	Transferrin	Change in transferrin	12 weeks - from baseline to end of study
Secondary	Ferritin	Change in ferritin	12 weeks - from baseline to end of study
Secondary	Folate	Change in folate	12 weeks - from baseline to end of study
Secondary	Vitamin B-12	Change in vitamin B-12	12 weeks - from baseline to end of study
Secondary	Magnesium	Change in magnesium	12 weeks - from baseline to end of study
Secondary	Zinc	Change in zinc	12 weeks - from baseline to end of study
Secondary	U-alb-crea Ratio	Change in urine albumin-creatinine ratio	12 weeks - from baseline to end of study
Secondary	Supar	Change in Supar	12 weeks - from baseline to end of study
Secondary	CRP	Change in CRP	12 weeks - from baseline to end of study
Secondary	IL-1	Change in IL-1	12 weeks - from baseline to end of study
Secondary	IL-6	Change in IL-6	12 weeks - from baseline to end of study
Secondary	IL-8	Change in IL-8	12 weeks - from baseline to end of study
Secondary	TNF-alpha	Change in TNF-alpha	12 weeks - from baseline to end of study