NCT03544892

Brief Summary

This randomized, crossover nutrition intervention seeks to examine the effects of a non-ketogenic low carbohydrate (CHO) diet (60-80g per day) on glycemic control, lipids, and markers on inflammation in individuals with Type 1 Diabetes (T1D). This study will be used to inform clinical practice, especially in teaching medical nutrition therapy to new-onset diabetes patients and those struggling with glycemic control and hyperlipidemia. At this time, no evidenced-based universal recommendations from randomized controlled trials exist to support low carbohydrate dietary patterns as a front-line approach in individuals with T1D. The investigators hypothesize a diet consisting of 60-80 g carbohydrate diet will result in greater improvement in glycemic control compared to a 50% carbohydrate diet in patients with Type 1 diabetes over 12 weeks in the outpatient setting.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

May 7, 2018

Last Update Submit

January 9, 2020

Conditions

Diabetes Mellitus, Type 1

Keywords

Low carbohydrate diet

Outcome Measures

Primary Outcomes (1)

  • Time in Range

    Difference in time spent with glucose values between 70-180 mg/dL assessed by continuous glucose monitoring (CGM)

    5 days of worn CGM during each intervention

Secondary Outcomes (33)

  • Mean Glucose

    Baseline to 12 weeks (1 week worn CGM data)

  • Standard deviation of glucose

    Baseline to 12 weeks (1 week worn CGM data)

  • Mean amplitude of glycemic excursions

    Baseline to 12 weeks (1 week worn CGM data)

  • Time in hypoglycemia

    Baseline to 12 weeks (1 week worn CGM data)

  • Time in hyperglycemia

    Baseline to 12 weeks (1 week worn CGM data)

  • +28 more secondary outcomes

Study Arms (2)

Experimental: Low carbohydrate diet

EXPERIMENTAL
Other: Low carbohydrate diet

Experimental: Standard of care diet

ACTIVE COMPARATOR
Other: Standard of care diet

Interventions

Low carbohydrate dietOTHER

60-80 g total carbohydrate per day

Experimental: Low carbohydrate diet
Standard of care dietOTHER

\> 150 g total carbohydrate per day

Experimental: Standard of care diet

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Confirmed Type 1 diabetes for \> 1 year confirmed by physician diagnosis
  • HbA1c \>5.9% and \<10%;
  • Confirmation of minimum three blood glucose tests per day (meter download or chart record)
  • Use of continuous subcutaneous insulin infusion therapy (CSII) or multiple daily injection (MDI) intensive insulin therapy
  • No change in insulin therapy type (CSII or MDI) in last 2 months or longer
  • Willingness to count carbohydrate and use bolus calculator on insulin pump during the intervention periods
  • Willingness to wear a 7 day CGM at three different time points during the study

You may not qualify if:

  • Females of childbearing potential who are pregnant or intend to become pregnant, are exclusively breastfeeding, or who are not using adequate contraceptive methods
  • Use of corticosteroids during or within 30 days prior to the intervention periods
  • Macroalbuminuria
  • Active proliferative retinopathy combined with an HbA1c ≥ 9%
  • Known or suspected alcohol or drug abuse
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Harold Hamm Diabetes Center

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Christina M Crowder, RDN, CNSC, LD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study uses 33 week randomized, powered study design to measure glycemic control with a low carbohydrate dietary pattern versus standard of care diabetes medical nutrition therapy. Each arm is 12 weeks with an 8 week washout between arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2018

First Posted

June 4, 2018

Study Start

May 1, 2018

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

US(1)