Clinical trial NCT05872711: Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes
Official title: Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Adolescents
Glycemic targets
Low carbohydrate diet
Mediterranean diet
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a randomized, parallel assignment clinical trial without blinding (open label) due to the impracticality of blinding diets
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the effect of low carbohydrate diet versus Mediterranean diet on blood sugar values in adolescents with type 1 diabetes.

The main question aims to answer whether a low carbohydrate diet is as effective as the Mediterranean diet for better glycaemic control in type 1 adolescents.

The investigators are also aiming to check whether low carbohydrate diet is safe and does not elevate cholesterol blood levels and whether the diet is adherable among youth with type 1 diabetes.

Participants with type 1 diabetes wearing a continuous glucose monitor and that will sign an informed consent will be randomly selected for 2 groups. One group will get the Mediterranean diet program and the other will get the low carbohydrate diet program, both for a duration of six months. Each participant will attend a cooking workshop at the beginning of the study. Blood work and stool samples will be taken at the beginning and 3 times through the study periodd. Each participant will attend meetings with the dietician thorough the period of the study.

Detailed description: Background and objective: Improved glycemic control of type 1 diabetes (T1DM), with low rates of adverse events was reported via an online community of children and adults who consume a of low carbohydrate diet (LCD). The investigators aim to compare the effects of a low carbohydrate diet (LCD) with those of a Mediterranean diet on glycemic control, lipid profile, bone metabolites and the microbiome profile in adolescents with type 1 diabetes.

Design A randomized, controlled trail. Families of adolescents in the Diabetes clinic in Edmond and Lily Safra Children's Hospital will be approached and offered to participate in a dietary intervention study. After participants will sign the informed consent, they will randomly be assigned into 2 diet treatment groups, the LCD (n=20) and the Mediterranean diet (n=20). Baseline nutrition teaching session and training and will be conducted for all participants and their parents. Participants will attend visit with the dietician at baseline, 2, 4, 8,12 weeks and will be given a 3-day food dairy to complete twice in that period. Measurements of weight, height, blood pressure, HbA1c, Time in range, number of hypoglycemia, lipid profile, creatinine, bone metabolites will be measured at baseline and 12 and 24 weeks and gut bacteria profile at baseline and at 24 weeks. Personality, quality of life, and socioeconomic questionnaires will be given to children and their parents.

Contribution of the suggested research:

In this research the investigators are aiming to show that LCD is as good as Mediterranean diet with improved glycemic control, safe, and adherable for adolescent with T1D.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Connected to a continuous glucose monitoring (CGM)

Exclusion Criteria:

* History of eating disorder
* Family history of mental disorders

Primary outcomes:
measure: Change of time in range (TIR) 70-180 mg/dl after following a LCD or a MD in adolescents with T1DM.
timeFrame: The change of TIR between baseline and after six months
Secondary outcomes:
measure: Evaluation of the influence of LCD vs. MD on HbA1c.
timeFrame: The change between baseline and after six months
measure: Assessment of the impact of dietary changes after an LCD vs. MD on gut dysbiosis
timeFrame: The change between baseline and after six months
measure: Assessment of the impact of both diets on bone turnover measures.
timeFrame: The change of bone turnover at baseline and after six months
measure: Assessment of the impact of dietary changes after an LCD vs. MD on quality of life.
timeFrame: The change between baseline and after six months in the quality of life.
measure: Change in BMI after LCD vs. MD
timeFrame: BMI change at baseline and after six months
measure: Change in diet LCD vs. MED
timeFrame: Baseline and after six months
measure: Change in LDL cholesterol
timeFrame: Baseline and after 6 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
affiliation: Head oh Pediatric Endocrinology Unit
name: Orit Pinhas-Hamiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.
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.