The Effects of a Low Carbohydrate, Non-Ketogenic Diet Versus Standard Diabetes Diet on Glycemic Control in Type 1 Diabetes

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT03544892

Run by

University of Oklahoma

People needed

11

Starts

2018-05-01

Expected to finish

2019-06-28

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Oklahoma Harold Hamm Diabetes Center — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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