Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes

NCT04082884 | Completed Results DMC

• 2 other identifiers: 20000261892K12DK094714-06
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet.

Conditions

Type 1 Diabetes

Keywords

very low carbohydrate diet

Outcome Measures

Primary Outcomes (1)

• Percentage of Time in Target Range of 70-180 mg/dL.

  The target range is 70 mg/dL - 180 mg/dL based on sensor-derived glucose levels. The outcome is reflected as the percentage of time spent in this range during the time frame.

  2 weeks per intervention, up to 7 weeks

Secondary Outcomes (6)

• Percentage of Time Spent > 180 mg/dL to 250 mg/dl

  2 weeks per intervention, up to 7 weeks

• Percent Time Spent > 250 mg/dL Based on Sensor-derived Glucose Values

  2 weeks per intervention, up to 7 weeks

• Percent of Time Spent > = 55 to < 70 mg/dL Based on Sensor-derived Glucose Values

  2 weeks per intervention, up to 7 weeks

• Percent Time Spent < 55 mg/dL Based on Sensor-derived Glucose Values

  2 weeks per intervention, up to 7 weeks

• Total Daily Insulin Dose

  2 weeks per intervention, up to 7 weeks

Study Arms (1)

Very Low Carbohydrate Diet

EXPERIMENTAL

Participants will follow a high protein very low carbohydrate diet (VLCD) for 2 weeks. This will be 11% of caloric intake from carbohydrates, 54% of calories from protein, and 35% of calories from fat. Immediately following this, participants will follow a high protein very low carbohydrate diet (VLCD) which will be 11% of caloric intake from carbohydrates, 23% of calories from protein, and 66% of calories from fat.

Behavioral: Very Low Carbohydrate Diet

Interventions

Very Low Carbohydrate Diet BEHAVIORAL

A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.

Very Low Carbohydrate Diet

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• BMI 19-30 m2 for individuals at least 18 years old or BMI \< 95 percentile for individuals less than 18 years old
• Participants 18 years of age must be able to read and provide written consent
• Participants under 18 years of age must be able to read and provide written assent
• Participants are managed using an insulin pump or injections
• Participant has or is willing to wear a CGM for the duration of the study
• Participant is willing to complete diet logging procedures stated above

You may not qualify if:

• A1c \< 6.5% or \> 10%
• Recent history of more than 1 of diabetic ketoacidosis (DKA) in the past 6 months
• Treatment with glucose-lowering drugs other than insulin
• Unstable psychiatric disorders, including eating disorders (DSM-V criteria)
• Weight loss medications within the last 6 months
• Females who are pregnant, lactating or planning to become pregnant in the next 6 months
• Another medical condition that precludes participation in the study

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Laura Marie Nally, MD
• Organization: Yale School of Medicine

laura.nally@yale.edu

(877) 925-3637

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Following enrollment, participants will follow a standard carbohydrate diet for 2 weeks. They will then undergo a 1 week transition followed by 2 weeks on a higher protein very low carbohydrate diet that is then followed by 2 weeks on a higher fat very low carbohydrate diet.

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 9, 2019
• Study Start: June 25, 2020
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: February 15, 2024
• Results First Posted: June 5, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)