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Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

Primary Purpose

Type1diabetes, Low Carbohydrate Diet

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

low carbohydrate diet

standard carbohydrate diet

About this trial

This is an interventional prevention trial for Type1diabetes, Low Carbohydrate Diet

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of type 1 diabetes for at least 1 year
Hemoglobin A1c level < 10% within the past 2 months
Provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is <18 years old.
Stated willingness to comply with all study procedures and availability for the duration of the study
Male, female, transgender, nonbinary are all eligible
Diagnosis of type 1 diabetes for at least 1 year
Insulin pump use for at least 2 months.
Ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal.
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

Current use of glucose-lowering agents other than insulin
Unstable psychiatric disorders, including eating disorders
Weight loss medications within the last 6 months
Pregnancy or lactation, or planning pregnancy within the next 6 months
BMI < 19 kg/m2 for individuals 18 years of age or older
BMI < 5%ile for individuals under 18 years
Weight less than 49 kg or 108 pounds
Other medical conditions that may interfere with glucose metabolism and insulin sensitivity

Sites / Locations

Yale-New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low carbohydrate diet

standard carbohydrate diet

Arm Description

In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the low carbohydrate group will limit carbohydrate intake to 15% of total daily calories.

In this crossover study, participants will be randomized to either a low or standard carbohydrate for 2 weeks. Participants in the standard carbohydrate group will follow an ad libitum diet with standard carbohydrate intake.

Outcomes

Primary Outcome Measures

Time in the optimal glucose range

Time in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during 2 weeks the diet.

Secondary Outcome Measures

Time spent with hypoglycemia.

Time spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic (<54 mg/dL, <70 mg/dL) ranges during 2 weeks of diet.

Time spent with hyperglycemia

Time spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic (>180 mg/dL, >250 mg/dL) ranges during 2 weeks of diet.

Full Information

NCT ID

NCT04955691

First Posted

July 1, 2021

Last Updated

April 6, 2023

Sponsor

Yale University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04955691

Brief Title

Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

Official Title

Metabolic and Neurological Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2021 (Actual)

Primary Completion Date

December 15, 2024 (Anticipated)

Study Completion Date

December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.

Detailed Description

The primary objective of this randomized crossover study is to determine whether a very low carbohydrate diet improves glycemic changes (measured by continuous glucose monitors) when compared to a standard carbohydrate diet in youth with type 1 diabetes. The secondary objectives of the study are to compare metabolic changes after 2 weeks on each diet using the 2-step hyperinsulinemic euglycemic-hypoglycemic clamp and stable isotope infusions. The euglycemic portion of the clamp will allow us to determine the hepatic glucose production and adipose tissue lipolysis. Secondary objectives also include measuring the neurohormonal response to hypoglycemia after 2 weeks on each diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1diabetes, Low Carbohydrate Diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

low carbohydrate diet

Arm Type

Experimental

Arm Description

Arm Title

standard carbohydrate diet

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

low carbohydrate diet

Intervention Description

Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.

Intervention Type

Other

Intervention Name(s)

standard carbohydrate diet

Intervention Description

Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.

Primary Outcome Measure Information:

Title

Time in the optimal glucose range

Description

Time in the optimal glucose range will be operationally defined as the percent time spent in the target range of 70-180 mg/dL during 2 weeks the diet.

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Time spent with hypoglycemia.

Description

Time spent with hypoglycemia will be operationally defined as the percent time spent in the hypoglycemic (<54 mg/dL, <70 mg/dL) ranges during 2 weeks of diet.

Time Frame

2 weeks

Title

Time spent with hyperglycemia

Description

Time spent with hyperglycemia will be operationally defined as the percent time spent in the hyperglycemic (>180 mg/dL, >250 mg/dL) ranges during 2 weeks of diet.

Time Frame

2 weeks

Other Pre-specified Outcome Measures:

Title

Human Factors

Description

To describe how participants feel about and react to following a very low carbohydrate diet, interviews will be conducted. Data will be coded and emerging patterns will be combined into descriptive themes.

Time Frame

8 weeeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of type 1 diabetes for at least 1 year Hemoglobin A1c level < 10% within the past 2 months Provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is <18 years old. Stated willingness to comply with all study procedures and availability for the duration of the study Male, female, transgender, nonbinary are all eligible Diagnosis of type 1 diabetes for at least 1 year Insulin pump use for at least 2 months. Ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner Exclusion Criteria: Current use of glucose-lowering agents other than insulin Unstable psychiatric disorders, including eating disorders Weight loss medications within the last 6 months Pregnancy or lactation, or planning pregnancy within the next 6 months BMI < 19 kg/m2 for individuals 18 years of age or older BMI < 5%ile for individuals under 18 years Weight less than 49 kg or 108 pounds Other medical conditions that may interfere with glucose metabolism and insulin sensitivity

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura M Nally, M.D.

Phone

203-785-5831

laura.nally@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Carol Alexandrescu, M.S.

Phone

203-785-7022

carol.alexandrescu@yale.edu

Facility Information:

Facility Name

Yale-New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Nally, MD

Phone

203-785-5831

laura.nally@yale.edu

First Name & Middle Initial & Last Name & Degree

Amy Steffen

Phone

203-737-8852

12. IPD Sharing Statement

Learn more about this trial

Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes

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