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

Diabetes Mellitus, Type 1 Clinical Trial

— T1DLoCHO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03544892
• Other study ID #: 8840
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: January 2020
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Type 1 diabetes mellitus (T1D) is marked by total insulin dependence with challenges regarding glycemic control and concomitant sequela. While standard of care medical nutrition therapy for this disease centers on matching carbohydrate to insulin at meals, recent literature and clinical reports have shown superior glycemic control and cardiovascular measures with lower carbohydrate dietary patterns (<130g/day) as compared to the standard American MyPlate (50% total calories as carbohydrate) approach. Diabetes management has evolved tremendously in the last twenty years with the development of sophisticated insulin pumps and continuous glucose monitors; but, glycemic control is still dependent on quantification of carbohydrate, imperfect in the real-world setting. Due to inherent error in carbohydrate counting, the investigators propose that less carbohydrate will produce better glycemic control by minimizing error and subsequent variation in individuals with type 1 diabetes.

There has long been a movement in the medical community to prescribe low carbohydrate diets under the premise of "less carbohydrate, less insulin, less glycemic variation". This strategy centers on "the law of small numbers", a calculus principle describing magnitude of variation in the output (glycemic variation) as the function of input size (CHO + insulin). Carbohydrate counting tends to result in ~50% error while there is ~30% variation in insulin action, making exactitude impossible. However, low CHO diets tend to provide >40% energy from fat due to the macronutrient distribution. With innate risk of cardiovascular disease in T1D, standard of care has supported restriction of total fat consumption, especially saturated fat, in effort to control cholesterol. While the American Diabetes Association recognizes that dietary fat is a controversial and complex issue, eliminating trans-fats is the only consensus point across the field. To date, most low CHO diet studies in both T1D and Type 2 Diabetes (T2D) have not shown adverse effects on lipids and tend to show decreases in triglycerides and either no change or increases in HDL, LDL, and total cholesterol.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• Low carbohydrate diet
60-80 g total carbohydrate per day
• Standard of care diet
> 150 g total carbohydrate per day

Locations

Country	Name	City	State
United States	University of Oklahoma Harold Hamm Diabetes Center	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Glucose	Difference in mean glucose values assessed by CGM	Baseline to 12 weeks (1 week worn CGM data)
Secondary	Standard deviation of glucose	Difference in standard deviation of glucose values assessed by CGM	Baseline to 12 weeks (1 week worn CGM data)
Secondary	Mean amplitude of glycemic excursions	Difference in mean amplitude of glycemic excursions assessed by CGM	Baseline to 12 weeks (1 week worn CGM data)
Secondary	Time in hypoglycemia	Difference in time spent with glucose values <70 mg/dL; between 55-70 mg/dL; and <55 mg/dL	Baseline to 12 weeks (1 week worn CGM data)
Secondary	Time in hyperglycemia	Difference in time spent with glucose values >180 mg/dL	Baseline to 12 weeks (1 week worn CGM data)
Secondary	Change in HbA1c	Difference in change in hemoglobin A1c	Baseline to 12 weeks
Secondary	Coefficient of Variation	Estimate of glucose variability calculated by dividing the standard deviation by average glucose	Baseline to 12 weeks (1 week worn CGM data)
Secondary	Severe hypoglycemia	Difference in number of severe hypoglycemia episodes (glucagon or IV dextrose administration)	Baseline to 12 weeks
Secondary	Total daily insulin dose	Difference in total daily insulin dose	Baseline to 12 weeks
Secondary	Total daily basal insulin 24 hour	Difference in total daily basal insulin in 24 hours	Baseline to 12 weeks
Secondary	Total daily bolus insulin 24 hour	Difference in total daily bolus insulin in 24 hours	Baseline to 12 weeks
Secondary	Body weight	Change in body weight	Baseline to 12 weeks
Secondary	Body Mass Index (BMI)	Change in BMI	Baseline to 12 weeks
Secondary	Systolic Blood Pressure (mm Hg)	Change in systolic BP	Baseline to 12 weeks
Secondary	Diastolic Blood Pressure (mm Hg)	Change in diastolic BP	Baseline to 12 weeks
Secondary	Pulse, per minute	Change in pulse	Baseline to 12 weeks
Secondary	Energy Intake (kcal/day)	Change in energy intake	Baseline to 12 weeks
Secondary	Daily carbohydrate intake (total carbohydrate, g/day)	Change in carbohydrate intake	Baseline to 12 weeks
Secondary	Percent energy intake as Carbohydrate	Change in % carbohydrate intake	Baseline to 12 weeks
Secondary	Daily protein intake (total protein, g/day) and Daily fat intake (total fat, g/day)	Change in protein intake	Baseline to 12 weeks
Secondary	Fat quality intake (% total fat as monounsaturated, polyunsaturated, saturated, omega-3)	Change in fat quality	Baseline to 12 weeks
Secondary	Standard Lipid Panel	Change in (Total cholesterol, HDL cholesterol, LDL cholesterol-calculated, triglycerides; mg/dL)	Baseline to 12 weeks
Secondary	LDL-P (nmol/L)	Change in LDL-P	Baseline to 12 weeks
Secondary	HDL-P (umol/L)	Change in HDL-P	Baseline to 12 weeks
Secondary	VLDL-P	Change in VLDL-P (nmol/L)	Baseline to 12 weeks
Secondary	LDL size	Change in LDL size (nm)	Baseline to 12 weeks
Secondary	HDL size	Change in HDL size (nm)	Baseline to 12 weeks
Secondary	VLDL size	Change in VLDL size (nm)	Baseline to 12 weeks
Secondary	High-sensitive C-reactive protein (hs-CRP)	Change in hs-CRP	Baseline to 12 weeks
Secondary	Plasma lipopolysaccharide	Surrogate marker for inflammation	Baseline to 12 weeks
Secondary	Serum Ketones (beta-hydroxybutyrate)	beta-hydroxybutyrate (mmol/L)	Baseline to 12 weeks
Secondary	Type 1 Diabetes Nutrition Knowledge Survey	Validated nutrition knowledge survey (nutrition label reading, carbohydrate counting)	Baseline to Week 33 (end of study)
Secondary	Diet Quality	Minerals, Vitamins, Dietary Fiber amounts compared to DRIs for age, ascertained by 3 day 24 hour food logs	Baseline to 12 weeks