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

Hvidovre University Hospital14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Low carbohydrate dietOTHER

High carbohydrate dietOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hvidovre University Hospital

Hvidovre, Denmark

Outcomes

Primary Outcomes

Percentage of Time Spent in Euglycemia

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 Outcomes

Mean Glucose

Mean glucose value assessed by continuous glucose monitoring

Time frame: 12 weeks - from baseline to end of study

Standard Deviation of Glucose

Standard deviation of glucose values assessed by continuous glucose monitoring

Time frame: 12 weeks - from baseline to end of study

Coefficient of Variation of Glucose

Coefficient of variation of glucose values assessed by continuous glucose monitoring

Time frame: 12 weeks - from baseline to end of study

Mean Amplitude of Glycemic Excursions

Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring

Time frame: 12 weeks - from baseline to end of study

Time Spent in Hypoglycemia

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

Time Spent in Hyperglycemia

Time spent with glucose values \> 10.0 mmol/l assessed by continuous glucose monitoring

Time frame: 12 weeks - from baseline to end of study

Change in A1c

Data from ClinicalTrials.gov

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Change in hemoglobin A1c

Time frame: From baseline to 12 weeks

AUC Low

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

AUC High

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

Post Breakfast Glucose Excursion

Difference in post breakfast glucose excursion assessed by continuous glucose monitoring

Time frame: 12 weeks - from baseline to end of study

Severe Hypoglycemia

Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)

Time frame: From baseline to 12 weeks

Total Daily Dose

Total daily insulin dose

Time frame: 12 weeks - from baseline to end of study

Total Daily Basal Insulin 24 Hour

Total daily basal insulin dose in the time range 00:00-24:00

Time frame: 12 weeks - from baseline to end of study

Total Nightime Basal Insulin

Total nighttime basal insulin in the time range 00:00-06:00

Time frame: From baseline to 12 weeks

Total Daytime Basal Insulin

Total daytime basal insulin in the time range 06:00-24:00

Time frame: 12 weeks - from baseline to end of study

Total Daily Bolus Insulin

Difference in total daily bolus insulin

Time frame: 12 weeks - from baseline to end of study

Blood Glucose Readings

Number of blood glucose readings

Time frame: 12 weeks - from baseline to end of study

Carbohydrate Servings

Number of daily carbohydrate servings (one serving ≥ 15 grams)

Time frame: 12 weeks - from baseline to end of study

Body Composition

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

Weight

Change in weight

Time frame: 12 weeks - from baseline to end of study

Hip Circumference

Change in hip circumference

Time frame: 12 weeks - from baseline to end of study

Waist Circumference

Change in waist circumference

Time frame: From baseline to 12 weeks

Systolic Blood Pressure

Change in systolic blood pressure

Time frame: 12 weeks - from baseline to end of study

Diastolic Blood Pressure

Change in diastolic blood pressure

Time frame: 12 weeks - from baseline to end of study

Heart Rate

Change in heart rate

Time frame: 12 weeks - from baseline to end of study

Diabetes Treatment Satisfaction

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

Hypoglycemia Fear

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

Cholesterol

Change in total cholesterol

Time frame: 12 weeks - from baseline to end of study

HDL

Change in HDL

Time frame: 12 weeks - from baseline to end of study

LDL

Change in LDL

Time frame: 12 weeks - from baseline to end of study

Triglycerides

Change in triglycerides

Time frame: 12 weeks - from baseline to end of study

Free Fatty Acids

Change in free fatty acids

Time frame: 12 weeks - from baseline to end of study

Sodium

Change in sodium

Time frame: 12 weeks - from baseline to end of study

Potassium

Change in potassium

Time frame: 12 weeks - from baseline to end of study

Creatinine

Change in creatinine

Time frame: 12 weeks - from baseline to end of study

Urate

Change in urate

Time frame: 12 weeks - from baseline to end of study

Albumin

Change in albumin

Time frame: 12 weeks - from baseline to end of study

Hemoglobin

Change in hemoglobin

Time frame: 12 weeks - from baseline to end of study

Leucocytes

Change in leucocytes

Time frame: 12 weeks - from baseline to end of study

Thrombocytes

Change in thrombocytes

Time frame: 12 weeks - from baseline to end of study

Iron

Change in iron

Time frame: 12 weeks - from baseline to end of study

Transferrin

Change in transferrin

Time frame: 12 weeks - from baseline to end of study

Ferritin

Change in ferritin

Time frame: 12 weeks - from baseline to end of study

Folate

Change in folate

Time frame: 12 weeks - from baseline to end of study

Vitamin B-12

Change in vitamin B-12

Time frame: 12 weeks - from baseline to end of study

Magnesium

Change in magnesium

Time frame: 12 weeks - from baseline to end of study

Zinc

Change in zinc

Time frame: 12 weeks - from baseline to end of study

U-alb-crea Ratio

Change in urine albumin-creatinine ratio

Time frame: 12 weeks - from baseline to end of study

Supar

Change in Supar

Time frame: 12 weeks - from baseline to end of study

CRP

Change in CRP

Time frame: 12 weeks - from baseline to end of study

IL-1

Change in IL-1

Time frame: 12 weeks - from baseline to end of study

IL-6

Change in IL-6

Time frame: 12 weeks - from baseline to end of study

IL-8

Change in IL-8

Time frame: 12 weeks - from baseline to end of study

TNF-alpha

Change in TNF-alpha

Time frame: 12 weeks - from baseline to end of study