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

NCT ID: NCT04082884

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2022-02-20

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.

Detailed Description

First, to evaluate the feasibility of following each type of VLCD (high protein or high fat), participants will follow a standard carbohydrate diet for 2 weeks, followed by a 1 week transition to a VLCD, and then follow the a high protein VLCD for 2 weeks followed by a high fat VLCD for 2 weeks. The study will consist of 4 in person or virtual visits which will take place over ~7 weeks. All participants will be initially studied for 2 weeks while ingesting a standard diet recommended by the American Diabetes Association, followed by a 1-week transition to a VLCD, and followed by 2 weeks on each type of VLCD (high protein, high fat). During the first (baseline) period fasting β-hydroxybutyrate levels will be measured 2-3 times per week. During the VLCD study periods, fasting β-hydroxybutyrate levels will be measured daily in the morning using a blood ketone meter; insulin doses will be collected using insulin pump downloads and continuous glucose monitoring (CGM) profiles will be used to assess glycemic excursions on each diet, as well as the time in hypo-, eu- and hyperglycemic ranges. The purpose of this study is to examine changes in sensor glucose levels, basal and bolus insulin doses, and metabolic factors following implementation of a very low carbohydrate diet (VLCD). Sensor-derived time glucose ranges will serve as a surrogate marker of hemoglobin A1c given the short duration of the study. Safety measures of the diet will also be assessed, including daily fasting ketone levels.

The first hypothesis of the study is that use of a VLCD with strict monitoring of ketosis will reduce glycemic variability and increase time in target range, defined as 70-180 mg/dL by reducing the time in the hyperglycemic (>180 mg/dL) and hypoglycemic ranges (<70 mg/dL). Decreased carbohydrate intake will lead to less postprandial hyperglycemia. Lower insulin doses for meals and snacks as a result of decreased carbohydrate intake will lessen postprandial hypoglycemia as well.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Very Low Carbohydrate Diet

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.

Group Type: EXPERIMENTAL

Very Low Carbohydrate Diet

Intervention Type: BEHAVIORAL

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

Interventions

Very Low Carbohydrate Diet

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale-New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2K12DK094714-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000026189

Identifier Type: -

Identifier Source: org_study_id