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NCT Number: NCT04944316

Effect of a Dietary Intervention on Insulin Requirements in Type 1 Diabetes

The purpose of this study is to compare the effects of a low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on the management of type 1 diabetes in adults. The primary outcome measure of this study is insulin requirements (measured as the total daily dose (TDD) of insulin or basal and bolus insulin units injected per day). The study duration is 12 weeks.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

About this study

Type 1 diabetes is a chronic autoimmune disorder characterized by loss of β-cell mass and function in the pancreas, leading to reduced secretion of insulin and hyperglycemia. The management of type 1 diabetes requires the administration of exogeneous insulin. Total daily dose (TDD) of insulin, a measure of the total amount of exogeneous insulin utilized per day, can be affected by multiple factors including insulin resistance, carbohydrate intake, body weight, and body composition. While the pathogenesis of type 1 diabetes and type 2 diabetes differ, a low-fat, plant-based diet has been shown to reduce insulin resistance, reduce body weight, improve body composition, and improve glycemic control in individuals with type 2 diabetes. A low-fat, plant-based diet has also been shown to improve β-cell function in individuals who are overweight. This finding is consistent with other research that shows that therapies that reduce body fat, or modify the distribution of body fat, improve β-cell function and glucose homeostasis. To date, a low-fat, plant-based diet has never been adequately tested in adults with type 1 diabetes. The purpose of this study is to compare the effects of low-fat, plant-based dietary intervention and a portion-controlled dietary intervention (compliant with current American Diabetes Association (ADA) guidelines) on insulin requirements in adults with type 1 diabetes.

Using a parallel group design, participants with type 1 diabetes will be randomly assigned to follow a low-fat, plant-based diet or a portion-controlled diet (compliant with current ADA guidelines) for 12 weeks. The principal dependent measures of this study are TDD of insulin, hemoglobin A1c (HbA1c), interstitial fluid glucose levels, and 24-hour carbohydrate: insulin ratio. Secondary and tertiary dependent measures include inflammatory biomarkers, blood lipids, body weight, diet quality, diet acceptability, and medication use.

The investigators hypothesize that both the low-fat, plant-based dietary intervention and the portion-controlled dietary intervention will elicit changes in insulin requirements, HbA1c, variability in interstitial glucose levels, insulin sensitivity, and body weight in participants with type 1 diabetes. The investigators further hypothesize that the low-fat, plant-based dietary intervention will confer a more substantial effect on changes in insulin requirements, HbA1c, insulin sensitivity, variability in interstitial glucose levels, and body weight in participants with type 1 diabetes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 diabetes
  • Men and women ≥ 18 years of age
  • Stable insulin regimen for past 3 months

Exclusion criteria

  • Type 2 or gestational diabetes
  • Body mass index ≥ 40 kg/m2
  • HbA1c ≥ 12.0%
  • Smoking or drug abuse during the past six months
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Unstable medical or psychiatric illness
  • Already following a low-fat vegan diet
  • Pregnant or breastfeeding, or plans of pregnancy within the study period
  • Lack of English fluency
  • Unable or unwilling to participate in all components of the study
  • Evidence of an eating disorder

Treatment and study plan

Dietary intervention

Behavioral

Low-fat, plant-based diet

Primary outcomes

  1. Total Insulin Dose

    Time frame: Change from week 0 to week 12

    A sum of basal and bolus insulin units (U) injected per day. An average from three (3) days (two (2) workdays and one (1) weekend day) will be utilized.

  2. Glycemic Control

    Time frame: Change from week 0 to week 12

    Hemoglobin A1c (HbA1c), an index of glycemic control, will be utilized.

  3. Glycemic Variability

    Time frame: Change from week 0 to week 12

    Glycemic variability will be assessed through use of a continuous glucose monitoring (CGM) system that will measure the concentration of glucose in the interstitial fluid. Participants will be instructed to wear a CGM (Dexcom g6 Platinum CGM System with an enhanced algorithm, software 505, Dexcom, Inc.) and record its readings at preset increments (after an overnight fast, before each meal, 2 hours after each meal, and before going to bed) daily. Participants will be prompted to submit CGM data to investigators on a weekly basis.

  4. 24-hour Carbohydrate to Insulin Ratio

    Time frame: Change from week 0 to week 12

    Calculated as the total number of grams (g) of dietary carbohydrate to total units (U) of insulin administered.

Secondary outcomes

  1. Body Weight

    Time frame: Change from week 0 to week 12

    Change in body weight measured on a calibrated scale.

  2. Concentration of Plasma Lipids

    Time frame: Change from week 0 to week 12

    Change in plasma cholesterol & triglycerides.

  3. High-sensitivity C-reactive Protein (hs-CRP)

    Time frame: Change from week 0 to week 12

    Implemented as a biomarker for absolute cardiovascular disease risk prediction.

  4. Tumor necrosis factor - α (TNF-α)

    Time frame: Change from week 0 to week 12

    Implemented to assess levels of systemic inflammation.

  5. Interleukin (IL) - 1 (IL-1) and interleukin-6 (IL-6)

    Time frame: Change from week 0 to week 12

    Implemented to assess levels of systemic inflammation.

  6. Food costs

    Time frame: 12 weeks

    Food costs will be assessed, using the U.S. Department of Agriculture Thrifty Food Plan, 2021, at baseline and 12 weeks.

  7. Insulin costs

    Time frame: 12 weeks

    Insulin costs will be assessed, using the Federal Supply Schedule (FSS) for insulin prices, at baseline and 12 weeks.

Other outcomes

  1. Medication Use

    Time frame: Change from week 0 to week 12

    Participants will be asked to report changes in their medication use.

  2. Diet Quality

    Time frame: Change from week 0 to week 12

    Dietary intake will be assessed using 3-day dietary records. Participants will be instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Records will be analyzed using Nutrition Data System for Research software version 2018, developed by the Nutrition Coordinating Center (NCC), University of Minnesota, Minneapolis, MN, US.

  3. Diet Acceptability

    Time frame: Change from week 0 to week 12

    The Food Acceptability Questionnaire (FAQ), a self-reported measure, will be implemented to assess the subjective responses (palatability; satisfaction; ease of preparation; financial feasibility; and perceived physical benefits) of participants to their baseline diets and the intervention diet. The FAQ has twelve (12) total questions. Eleven (11) of the questions are scored on a Likert scale (1-7) and one (1) unscored question (physical benefits) will prompt the participant to "check all that apply." A higher FAQ score corresponds with a more positive subjective response.

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Official study title

Physicians Committee for Responsible Medicine - a Randomized, Controlled Study of the Effect of a Low-fat, Plant-based Diet on Insulin Requirements in Individuals with Type 1 Diabetes

Acronym: T1D

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2021
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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