AzTrials
AzTrials

Type 1 DiabetesHiLo12NCT02888691

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

A study testing Low carbohydrate diet and High carbohydrate diet in people with Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Low carbohydrate diet and High carbohydrate diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteDenmark
Study dates
Aug 2016to Nov 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hvidovre University Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

Official title: Low Carbohydrate Diet vs. High Carbohydrate Diet in Type 1 Diabetes: A Randomized Crossover Study

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
Being tested
Low carbohydrate diet, High carbohydrate diet
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low carbohydrate dietOther

  • High carbohydrate dietOther

Study groups in NCT02888691
Study groupRoleWhat they receive
Low Carbohydrate DietExperimental< 100 grams of carbohydrate per day
Receives: Other: Low carbohydrate diet
High Carbohydrate DietExperimental> 250 grams of carbohydrate per day
Receives: Other: High carbohydrate diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Time Spent in Euglycemia

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

    Measured: 12 weeks - from baseline to end of study

Secondary outcomes (54)

  1. Mean Glucose

    Mean glucose value assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  2. Standard Deviation of Glucose

    Standard deviation of glucose values assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  3. Coefficient of Variation of Glucose

    Coefficient of variation of glucose values assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  4. Mean Amplitude of Glycemic Excursions

    Mean amplitude of glycemic excursions (MAGE) assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  5. Time Spent in Hypoglycemia

    Percentage of time spent with glucose values ≤ 3.9 mmol/l assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  6. Time Spent in Hyperglycemia

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

    Measured: 12 weeks - from baseline to end of study

  7. Change in A1c

    Change in hemoglobin A1c

    Measured: From baseline to 12 weeks

  8. AUC Low

    Difference in area under the curve <4.0 mmol/l assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  9. AUC High

    Difference in area under the curve >10.0 mmol/l assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  10. Post Breakfast Glucose Excursion

    Difference in post breakfast glucose excursion assessed by continuous glucose monitoring

    Measured: 12 weeks - from baseline to end of study

  11. Severe Hypoglycemia

    Number of severe hypoglycemia episodes (glucagon or intravenous glucose administration)

    Measured: From baseline to 12 weeks

  12. Total Daily Dose

    Total daily insulin dose

    Measured: 12 weeks - from baseline to end of study

  13. Total Daily Basal Insulin 24 Hour

    Total daily basal insulin dose in the time range 00:00-24:00

    Measured: 12 weeks - from baseline to end of study

  14. Total Nightime Basal Insulin

    Total nighttime basal insulin in the time range 00:00-06:00

    Measured: From baseline to 12 weeks

  15. Total Daytime Basal Insulin

    Total daytime basal insulin in the time range 06:00-24:00

    Measured: 12 weeks - from baseline to end of study

  16. Total Daily Bolus Insulin

    Difference in total daily bolus insulin

    Measured: 12 weeks - from baseline to end of study

  17. Blood Glucose Readings

    Number of blood glucose readings

    Measured: 12 weeks - from baseline to end of study

  18. Carbohydrate Servings

    Number of daily carbohydrate servings (one serving ≥ 15 grams)

    Measured: 12 weeks - from baseline to end of study

  19. Body Composition

    Change in fat mass (% of total body weight) assessed by Dual-energy X-ray Absorptiometry

    Measured: 12 weeks - from baseline to end of study

  20. Weight

    Change in weight

    Measured: 12 weeks - from baseline to end of study

  21. Hip Circumference

    Change in hip circumference

    Measured: 12 weeks - from baseline to end of study

  22. Waist Circumference

    Change in waist circumference

    Measured: From baseline to 12 weeks

  23. Systolic Blood Pressure

    Change in systolic blood pressure

    Measured: 12 weeks - from baseline to end of study

  24. Diastolic Blood Pressure

    Change in diastolic blood pressure

    Measured: 12 weeks - from baseline to end of study

  25. Heart Rate

    Change in heart rate

    Measured: 12 weeks - from baseline to end of study

  26. Diabetes Treatment Satisfaction

    Change in Diabetes Treatment Satisfaction Questionnaire score. Score range: 0-36, with higher values representing higher degrees of treatment satisfaction.

    Measured: 12 weeks - from baseline to end of study

  27. Hypoglycemia Fear

    Change in Hypoglycemia Fear Survey score. Score range: 0-52, with higher scores indicating higher degrees of fear of hypoglycemia.

    Measured: 12 weeks - from baseline to end of study

  28. Cholesterol

    Change in total cholesterol

    Measured: 12 weeks - from baseline to end of study

  29. HDL

    Change in HDL

    Measured: 12 weeks - from baseline to end of study

  30. LDL

    Change in LDL

    Measured: 12 weeks - from baseline to end of study

  31. Triglycerides

    Change in triglycerides

    Measured: 12 weeks - from baseline to end of study

  32. Free Fatty Acids

    Change in free fatty acids

    Measured: 12 weeks - from baseline to end of study

  33. Sodium

    Change in sodium

    Measured: 12 weeks - from baseline to end of study

  34. Potassium

    Change in potassium

    Measured: 12 weeks - from baseline to end of study

  35. Creatinine

    Change in creatinine

    Measured: 12 weeks - from baseline to end of study

  36. Urate

    Change in urate

    Measured: 12 weeks - from baseline to end of study

  37. Albumin

    Change in albumin

    Measured: 12 weeks - from baseline to end of study

  38. Hemoglobin

    Change in hemoglobin

    Measured: 12 weeks - from baseline to end of study

  39. Leucocytes

    Change in leucocytes

    Measured: 12 weeks - from baseline to end of study

  40. Thrombocytes

    Change in thrombocytes

    Measured: 12 weeks - from baseline to end of study

  41. Iron

    Change in iron

    Measured: 12 weeks - from baseline to end of study

  42. Transferrin

    Change in transferrin

    Measured: 12 weeks - from baseline to end of study

  43. Ferritin

    Change in ferritin

    Measured: 12 weeks - from baseline to end of study

  44. Folate

    Change in folate

    Measured: 12 weeks - from baseline to end of study

  45. Vitamin B-12

    Change in vitamin B-12

    Measured: 12 weeks - from baseline to end of study

  46. Magnesium

    Change in magnesium

    Measured: 12 weeks - from baseline to end of study

  47. Zinc

    Change in zinc

    Measured: 12 weeks - from baseline to end of study

  48. U-alb-crea Ratio

    Change in urine albumin-creatinine ratio

    Measured: 12 weeks - from baseline to end of study

  49. Supar

    Change in Supar

    Measured: 12 weeks - from baseline to end of study

  50. CRP

    Change in CRP

    Measured: 12 weeks - from baseline to end of study

  51. IL-1

    Change in IL-1

    Measured: 12 weeks - from baseline to end of study

  52. IL-6

    Change in IL-6

    Measured: 12 weeks - from baseline to end of study

  53. IL-8

    Change in IL-8

    Measured: 12 weeks - from baseline to end of study

  54. TNF-alpha

    Change in TNF-alpha

    Measured: 12 weeks - from baseline to end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02888691
Sponsor's protocol ID
HiLo12
Acronym
HiLo12
Status last verified
Feb 2023
First submitted
30 Aug 2016
Last updated
28 Mar 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30924570

  • 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.

    PubMed 33855222

  • 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.

    PubMed 33855215

Questions about this trial

What is this clinical trial studying?

A study testing Low carbohydrate diet and High carbohydrate diet in people with Type 1 Diabetes, run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time Spent in Euglycemia (time frame: 12 weeks - from baseline to end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02888691, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in