Comparison of Low, Moderate and High Carbohydrate Diet on Insulin Requirements and Metabolic Control in Type 1 Diabetes

NCT03761186 | Unknown

• 1 other identifier: 2018/218-31
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The scientific basis for dietary recommendations in type 1 diabetes is almost lacking, with the current recommendations being based on type 2 diabetes studies. Therefore the overall purpose of this study is to improve the current evidence for dietary recommendations to people with type 1 diabetes. Study aim: To compare how a strictly low carbohydrate diet, a moderately low carbohydrate diet and a traditional diabetes diet (with higher amounts of carbohydrates) affect insulin requirements and metabolic control in individuals with type 1 diabetes. Carbohydrate intake is 50-60% of the total energy intake in the traditional diabetes diet, 30-40% in the moderately low carbohydrate diet and 15-20% in the strictly low carbohydrate diet with a minimum of 50 g carbohydrates/day. A diet with less than 50 g carbohydrates/day is usually called very low carbohydrate diet or ketogenic and will not be tested in this study. Those who wish to participate and meet the inclusion criteria (and none of the exclusion criteria) will be randomized to one of the three diets. The duration of the intervention is 6 months after which the participants will be able to choose their own diet for another 6 months. The main study visits are at baseline (screening and study start), 3, 6, 9, and 12 months. Shorter visits will be at 3 and 6 weeks. The participants will meet with a study nurse, dietitian and doctor. They will attend two carbohydrate counting courses before the start of the intervention in order to be able to match their insulin to the amount carbohydrates they eat. Participants will receive written materials about their diets with menus and recipes for better adherence to the diet. The primary endpoint is the change in insulin requirements within and between groups (for secondary endpoints please see relevant section). For assessing the different endpoints the participants will provide blood, urine and feces samples for lab analyses as well as register their insulin use, blood glucose, diet, physical activity and any blood ketones or hypoglycemia electronically or in written forms. Continuous/flash glucose monitoring (CGM/FGM) will be also used. Dietary assessment and adherence will be based on 3-4 day food diaries before every scheduled study visit.

Conditions

Type1diabetes

Keywords

type 1 diabetes; low carbohydrate diet; randomized trial; adults; insulin; metabolic control

Outcome Measures

Primary Outcomes (1)

• Change in insulin use

  measured in international units (IU) and percentage.

  screening, day 0, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (30)

• Change in HbA1c

  screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

• Change in concentration of total cholesterol

  screening, 3 months, 6 months, 9 months, 12 months

• Change in concentration of triglycerides

  screening, 3 months, 6 months, 9 months, 12 months

• Change in concentration of HDL-cholesterol

  screening, 3 months, 6 months, 9 months, 12 months

• Change in concentration of LDL-cholesterol

  screening, 3 months, 6 months, 9 months, 12 months

Other Outcomes (4)

• Carbohydrate intake

  screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

• Energy intake from carbohydrates

  screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

• Daily energy intake of participants

  screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months

Study Arms (3)

traditional diabetes diet

ACTIVE COMPARATOR

Participants in this arm will follow a diet with carbohydrate intake 50-60% of total energy intake

Behavioral: traditional diabetes diet

moderately low carbohydrate diet

EXPERIMENTAL

Participants in this arm will follow a diet with carbohydrate intake 30-40% of total energy intake

Behavioral: moderately low carbohydrate diet

strictly low carbohydrate diet

EXPERIMENTAL

Participants in this arm will follow a diet with carbohydrate intake 15-20% of total energy intake

Behavioral: strictly low carbohydrate diet

Interventions

traditional diabetes diet BEHAVIORAL

Diet with carbohydrate content 50-60% of total energy intake

traditional diabetes diet

moderately low carbohydrate diet BEHAVIORAL

Diet with carbohydrate content 30-40% of total energy intake

moderately low carbohydrate diet

strictly low carbohydrate diet BEHAVIORAL

Diet with carbohydrate content 15-20% of total energy intake

strictly low carbohydrate diet

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To have had type 1 diabetes for at least 1 year
• Age \>=20 years old

You may not qualify if:

• Cardiovascular disease NYHA class IIIB or more
• Kidney disease \> stadium 3
• Liver disease, alanine aminotransferase (ALAT) ≥ 2 µkat/L,
• BMI \< 18.5 kg/m\^2
• c-peptide ≥ 0.3 nmol/l
• Pregnant/breastfeeding women, women that plan to get pregnant during study period
• Other circumstances, which, according to the examiner, make it difficult for an individual to participate.

Sponsors & Collaborators

• Anneli Björklund: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Center for Diabetes, Academic Specialistcenter

Stockholm, 11365, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Officials

• Anneli Björklund, MD, PhD

  Department of Endocrinology at Karolinska University Hospital and Academic Specialistcentrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Nurses that will take lab samples as well as laboratory personal that analyses the samples will be masked. Due to the nature of the study, it is not possible to mask the participants or the care providers/investigators.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Senior Consultant, Associate Professor

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 3, 2018
• Study Start: December 12, 2018
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

SE (1)