Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes

NCT02888691 | Completed Results

• 1 other identifier: HiLo12
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate glycemic control during a low carbohydrate diet compared with during a high carbohydrate diet in adults with insulin pump treated type 1 diabetes.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Percentage of Time Spent in Euglycemia

  Time spent with glucose values 4.0-10.0 mmol/l assessed by continuous glucose monitoring

  12 weeks - from baseline to end of study

Secondary Outcomes (54)

• Mean Glucose

  12 weeks - from baseline to end of study

• Standard Deviation of Glucose

  12 weeks - from baseline to end of study

• Coefficient of Variation of Glucose

  12 weeks - from baseline to end of study

• Mean Amplitude of Glycemic Excursions

  12 weeks - from baseline to end of study

• Time Spent in Hypoglycemia

  12 weeks - from baseline to end of study

Other Outcomes (2)

• Carbohydrate Intake

  12 weeks - from baseline to end of study

• Ketones

  Spot test at week 0, 2, 4, 6, 8, 10 and 12

Study Arms (2)

Low Carbohydrate Diet

EXPERIMENTAL

\< 100 grams of carbohydrate per day

Other: Low carbohydrate diet

High Carbohydrate Diet

EXPERIMENTAL

\> 250 grams of carbohydrate per day

Other: High carbohydrate diet

Interventions

Low carbohydrate diet OTHER

Low Carbohydrate Diet

High carbohydrate diet OTHER

High Carbohydrate Diet

Eligibility Criteria

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

You may qualify if:

• Type 1 diabetes ≥3 years
• Insulin pump use ≥1 year
• HbA1c ≥53 mmol/mol (7.0%)
• BMI 20-27 kg/m2
• Willingness to count carbohydrates and use the insulin pump bolus calculator for all boluses during the intervention periods
• Willingness to use continuous glucose monitoring consistently during the intervention periods

You may not qualify if:

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
• Use of SGLT-2-inhibitors
• Use of corticosteroids during or within 30 days prior to the intervention periods
• Celiac disease
• Inflammatory bowel disease
• Macroalbuminuria
• Active proliferative retinopathy combined with an HbA1c ≥ 75 mmol/mol (9.0%)
• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (3)

• Schmidt S, Christensen MB, Serifovski N, Damm-Frydenberg C, Jensen JB, Floyel T, Storling J, Ranjan A, Norgaard K. Low versus high carbohydrate diet in type 1 diabetes: A 12-week randomized open-label crossover study. Diabetes Obes Metab. 2019 Jul;21(7):1680-1688. doi: 10.1111/dom.13725. Epub 2019 Apr 21.

  PMID: 30924570 RESULT

• Ji L, Li L, Ma J, Li X, Li D, Meng B, Lu W, Sun J, Liu Y, Takayanagi G, Wang Y. Efficacy and safety of teneligliptin added to metformin in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin: A phase 3, randomized, double-blind, placebo-controlled study. Endocrinol Diabetes Metab. 2021 Jan 20;4(2):e00222. doi: 10.1002/edm2.222. eCollection 2021 Apr.

  PMID: 33855222 DERIVED

• Al-Sari N, Schmidt S, Suvitaival T, Kim M, Trost K, Ranjan AG, Christensen MB, Overgaard AJ, Pociot F, Norgaard K, Legido-Quigley C. Changes in the lipidome in type 1 diabetes following low carbohydrate diet: Post-hoc analysis of a randomized crossover trial. Endocrinol Diabetes Metab. 2021 Jan 4;4(2):e00213. doi: 10.1002/edm2.213. eCollection 2021 Apr.

  PMID: 33855215 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate-Restricted; Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet, High-Protein

Results Point of Contact

• Title: Dr Signe Schmidt
• Organization: Steno Diabetes Center Copenhagen

signe.schmidt@regionh.dk

+4551174785

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 28, 2023
• Results First Posted: November 9, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)