Clinical trial NCT02888691: Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes
Official title: Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Time Spent in Euglycemia
timeFrame: 12 weeks - from baseline to end of study
Secondary outcomes:
measure: Mean Glucose
timeFrame: 12 weeks - from baseline to end of study
measure: Standard Deviation of Glucose
timeFrame: 12 weeks - from baseline to end of study
measure: Coefficient of Variation of Glucose
timeFrame: 12 weeks - from baseline to end of study
measure: Mean Amplitude of Glycemic Excursions
timeFrame: 12 weeks - from baseline to end of study
measure: Time Spent in Hypoglycemia
timeFrame: 12 weeks - from baseline to end of study
measure: Time Spent in Hyperglycemia
timeFrame: 12 weeks - from baseline to end of study
measure: Change in A1c
timeFrame: From baseline to 12 weeks
measure: AUC Low
timeFrame: 12 weeks - from baseline to end of study
measure: AUC High
timeFrame: 12 weeks - from baseline to end of study
measure: Post Breakfast Glucose Excursion
timeFrame: 12 weeks - from baseline to end of study
measure: Severe Hypoglycemia
timeFrame: From baseline to 12 weeks
measure: Total Daily Dose
timeFrame: 12 weeks - from baseline to end of study
measure: Total Daily Basal Insulin 24 Hour
timeFrame: 12 weeks - from baseline to end of study
measure: Total Nightime Basal Insulin
timeFrame: From baseline to 12 weeks
measure: Total Daytime Basal Insulin
timeFrame: 12 weeks - from baseline to end of study
measure: Total Daily Bolus Insulin
timeFrame: 12 weeks - from baseline to end of study
measure: Blood Glucose Readings
timeFrame: 12 weeks - from baseline to end of study
measure: Carbohydrate Servings
timeFrame: 12 weeks - from baseline to end of study
measure: Body Composition
timeFrame: 12 weeks - from baseline to end of study
measure: Weight
timeFrame: 12 weeks - from baseline to end of study
measure: Hip Circumference
timeFrame: 12 weeks - from baseline to end of study
measure: Waist Circumference
timeFrame: From baseline to 12 weeks
measure: Systolic Blood Pressure
timeFrame: 12 weeks - from baseline to end of study
measure: Diastolic Blood Pressure
timeFrame: 12 weeks - from baseline to end of study
measure: Heart Rate
timeFrame: 12 weeks - from baseline to end of study
measure: Diabetes Treatment Satisfaction
timeFrame: 12 weeks - from baseline to end of study
measure: Hypoglycemia Fear
timeFrame: 12 weeks - from baseline to end of study
measure: Cholesterol
timeFrame: 12 weeks - from baseline to end of study
measure: HDL
timeFrame: 12 weeks - from baseline to end of study
measure: LDL
timeFrame: 12 weeks - from baseline to end of study
measure: Triglycerides
timeFrame: 12 weeks - from baseline to end of study
measure: Free Fatty Acids
timeFrame: 12 weeks - from baseline to end of study
measure: Sodium
timeFrame: 12 weeks - from baseline to end of study
measure: Potassium
timeFrame: 12 weeks - from baseline to end of study
measure: Creatinine
timeFrame: 12 weeks - from baseline to end of study
measure: Urate
timeFrame: 12 weeks - from baseline to end of study
measure: Albumin
timeFrame: 12 weeks - from baseline to end of study
measure: Hemoglobin
timeFrame: 12 weeks - from baseline to end of study
measure: Leucocytes
timeFrame: 12 weeks - from baseline to end of study
measure: Thrombocytes
timeFrame: 12 weeks - from baseline to end of study
measure: Iron
timeFrame: 12 weeks - from baseline to end of study
measure: Transferrin
timeFrame: 12 weeks - from baseline to end of study
measure: Ferritin
timeFrame: 12 weeks - from baseline to end of study
measure: Folate
timeFrame: 12 weeks - from baseline to end of study
measure: Vitamin B-12
timeFrame: 12 weeks - from baseline to end of study
measure: Magnesium
timeFrame: 12 weeks - from baseline to end of study
measure: Zinc
timeFrame: 12 weeks - from baseline to end of study
measure: U-alb-crea Ratio
timeFrame: 12 weeks - from baseline to end of study
measure: Supar
timeFrame: 12 weeks - from baseline to end of study
measure: CRP
timeFrame: 12 weeks - from baseline to end of study
measure: IL-1
timeFrame: 12 weeks - from baseline to end of study
measure: IL-6
timeFrame: 12 weeks - from baseline to end of study
measure: IL-8
timeFrame: 12 weeks - from baseline to end of study
measure: TNF-alpha
timeFrame: 12 weeks - from baseline to end of study
Other outcomes:
measure: Carbohydrate Intake
timeFrame: 12 weeks - from baseline to end of study
measure: Ketones
timeFrame: Spot test at week 0, 2, 4, 6, 8, 10 and 12
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
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.
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.
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.