Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Low Carbohydrate Versus Mediterranean Diet in Adolescents With Type 1 Diabetes: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872711
• Other study ID #: SHEBA-18-5537-OH-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2023
• Source: Sheba Medical Center
• Contact: Orit Pinhas-Hamiel, MD
• Phone: +97235305015
• Email: Orit.hamiel[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Connected to a continuous glucose monitoring (CGM)

Exclusion Criteria:

• History of eating disorder

• Family history of mental disorders

Related Conditions & MeSH terms

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

Intervention

Other:
• Low carbohydrate diet
In order to maintain equal intensity of treatment, each patient will get a cooking workshop and received a personalized diet regime at baseline, based on the randomly assigned diet. Format and quality of the materials are similar. All diet plans are individualized and matched for energy intake personally . Participants will meet individually with the dietitian for diet instruction and support at week 1,2,4,7,10,12 and thereafter at 24 weeks for a total of seven frontal meetings. Twice during the first 12 weeks the dietician will conduct 10-15-minute motivational telephone calls with all the participants.

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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.201 — View 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):1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of time in range (TIR) 70-180 mg/dl after following a LCD or a MD in adolescents with T1DM.	Time spent in range (TIR) 70-180 mg/dl assessed by CGM was downloaded at each visit with the dietician. Severe hypoglycemia was defined as an episode requiring assistance and was confirmed by documentation of a blood glucose value less than 54 mg per deciliter	The change of TIR between baseline and after six months
Secondary	Evaluation of the influence of LCD vs. MD on HbA1c.	Blood test for Hba1c will be taken at baseline and 24 weeks. Insulin dose and glycemic variability will be taken at each visit with the dietician from=n the pump and sensor downloads.	The change between baseline and after six months
Secondary	Assessment of the impact of dietary changes after an LCD vs. MD on gut dysbiosis	Three stool samples will be take from each participant, and kept in -80c until being investigated in a lab	The change between baseline and after six months
Secondary	Assessment of the impact of both diets on bone turnover measures.	Blood samples will be taken from the participants after a 12-hr fast at baseline,12 and 24 weeks. Bone markers: procollagen type 1 amino-terminal propeptide (P1NP) and bone resorption C-terminal telopeptide of type 1 collagen (CTx1) as well as cholesterol, LDL cholesterol, triglyceride and HDL cholesterol.	The change of bone turnover at baseline and after six months
Secondary	Assessment of the impact of dietary changes after an LCD vs. MD on quality of life.	Quality of life questionnaire for type 1 diabetes adolescents will be given at baseline and after 6 months. A higher score reflects a better equality of life.	The change between baseline and after six months in the quality of life.
Secondary	Change in BMI after LCD vs. MD	Measured height and weight will be taken at baseline and after 6 months of intervention in both arms and will be calculated into BMI. The outcome is the change in BMI at baseline and at the end of the intervention.	BMI change at baseline and after six months
Secondary	Change in diet LCD vs. MED	FFQ (food frequency questionnaire) will be given at baseline and after 6 months to both arms, change of micronutrients and macronutrients will be calculated according to the questionnaire	Baseline and after six months
Secondary	Change in LDL cholesterol	Blood test will be taken at baseline and after six months of intervention. Change in LDL cholesterol before and after the diets.	Baseline and after 6 months