|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
5 July 2021 |
|
Main ID: |
NCT04943926 |
|
Date of registration:
|
21/06/2021 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Dietary Strategies for Remission of Type 2 Diabetes
CARBCOUNT |
|
Scientific title:
|
Dietary Strategies for Remission of Type 2 Diabetes - a Randomized Controlled Trial (CARBCOUNT) |
|
Date of first enrolment:
|
August 15, 2021 |
|
Target sample size:
|
750 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04943926 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
Pål R Njølstad |
|
Address:
|
|
|
Telephone:
|
+47 55 97 51 53 |
|
Email:
|
Pal.Njolstad@uib.no |
|
Affiliation:
|
|
|
|
Name:
|
Simon N Dankel, PhD |
|
Address:
|
|
|
Telephone:
|
+4794308637 |
|
Email:
|
Simon.Dankel@uib.no |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- HbA1c >48 mmol/mol (with or without medical treatment)
- Less than 6 years since the diagnosis of T2D
- BMI = 27 kg/m2 (=25 kg/m2 for Asians)
Exclusion Criteria:
- Treatment with insulin >25 IU
- HbA1c concentration of 12% or more (=108 mmol/mol)
- Insulin to C-peptide ratio <0.8 (indicative of insulin deficiency)
- Myocardial infarction within the previous 6 months, and severe or unstable heart
failure or other severe diseases including cancer, psychiatric/eating disorders,
severe depression and substance abuse
Age minimum:
24 Years
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes Mellitus, Type 2
|
|
Dyslipidemia Associated With Type II Diabetes Mellitus
|
|
Glucose Intolerance
|
|
Hypertension
|
|
Insulin Resistance
|
|
Overweight and Obesity
|
|
Intervention(s)
|
|
Other: Energy restricted diet
|
|
Other: Low carbohydrate high fat diet
|
|
Primary Outcome(s)
|
|
Diabetes remission
[Time Frame: 15 months]
|
|
Secondary Outcome(s)
|
|
Changes from baseline in the frequency of diabetes- and antihypertensive medication usage
[Time Frame: 3, 9 and 15 months]
|
|
Changes in eating behaviour from baseline and throughout the study
[Time Frame: 3, 9 and 15 months]
|
|
Changes in eating self-efficacy
[Time Frame: 3, 9 and 15 months]
|
|
Changes in estimated insulin resistance and beta cell function from baseline
[Time Frame: 3, 9 and 15 months]
|
|
Changes in fasting insulin and insulin C-peptide concentrations from baseline
[Time Frame: 3, 9 and 15 months]
|
|
Changes in HbA1c and fasting glucose concentrations from baseline
[Time Frame: 3, 9 and 15 months]
|
|
Changes in quality of life
[Time Frame: 3, 9 and 15 months]
|
|
Diabetes remission without anti-diabetes medications
[Time Frame: 3, 9 and 15 months]
|
|
Secondary ID(s)
|
|
CARBCOUNT Multicenter RCT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|