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

Not Applicable

Completed

Conditions: Type 1 Diabetes

Interventions: Other: Low carbohydrate diet
Other: High carbohydrate diet

Registration Number: NCT02888691

Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Carbohydrate Diet	Low carbohydrate diet	\< 100 grams of carbohydrate per day
High Carbohydrate Diet	High carbohydrate diet	\> 250 grams of carbohydrate per day

Primary Outcome Measures

Name	Time	Method
Percentage of Time Spent in Euglycemia	12 weeks - from baseline to end of study	Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring

Secondary Outcome Measures

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