- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03554590
DM1, Effects of Carbo-Counting on Glycemic Control
May 31, 2018 updated by: Emanuela Orsi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Effectiveness of Carbohydrate Counting on Glycaemic Control in T1DM Patients
Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy.
However, it may lead to weight gain and unhealthy eating habits.
This study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in T1DM patients who practice CHO-counting, after attending a structured course to learn how to manage this tecnique, vs a control Group, in a follow up period of 2 years.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
patients with type 1 DM will be enrolled in the study.
patients in the intervention group will attend a 5-lessons training to learn how to manage insulin therapy depending on the amount of carbohydrates in their meals, patients in the control group will be follow according to the the standard care.
after the follow up period glycometabolic, anthropometric parameters and dietary lifestyle changes will be compared between the two groups.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emanuela Orsi, MD
- Phone Number: 0255034590
- Email: emanuela_orsi@yahoo.it
Study Contact Backup
- Name: valeria grancini, MD
- Phone Number: 0039 3926233299
- Email: valeria_grancini@hotmail.it
Study Locations
-
-
-
Milan, Italy, 20133
- Recruiting
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
-
Contact:
- Valeria Grancini, MD
- Phone Number: 00393926233299
- Email: valeria_grancini@hotmail.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 1 diabetes mellitus
- insulin therapy
- HbA1c from 5.5 to 10%
Exclusion Criteria:
- pregnancy
- celiac disease
- hepatic impairment
- chronic renal failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: carbo-counters
carbohydrate counting: patients attending a structured carbohydrate-counting training and practicing this tecnique to manage insulin therapy
|
patients will attend a 5 meetings-structured training to learn how to manage their insulin therapy depending on the amount of carbohydrates contained in foods
|
Active Comparator: control group
insulin therapy according to standard care.
patients who don't practice carbohydrate-counting to manage insulin therapy
|
patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
glycemic control
Time Frame: 2 years
|
HbA1c
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anthropometric parameters: BMI
Time Frame: 2 years
|
variations in body mass index (BMI: units kg/m2), weight and height will be combined to report BMI in kg/m^2
|
2 years
|
anthropometric parameters: WAIST AND HIP CIRCUMFERENCE
Time Frame: 2 years
|
variations in waist and hip circumference (units: cm)
|
2 years
|
anthropometric parameters: BIOIMPEDENTIOMETRIC PARAMETERS
Time Frame: 2 years
|
fat mass and free fat mass (units: % of total mass)
|
2 years
|
dietary lifestyle
Time Frame: 2 years
|
variations in intake of simple sugars, animal protein rich foods, saturated fats and cholesterol, UDM: grams/die.
All the informations will be collected using 5days food diaries, completed by the patients.
|
2 years
|
glucose variability: mean and standard deviation of self monitoring blood glucose (SMBG)
Time Frame: 2 YEARS
|
mean and standard deviation of self monitoring blood glucose (SMBG), data collected from glucometers, units: mg/dl
|
2 YEARS
|
glucose variability: incidence of hypoglycaemia
Time Frame: 2 YEARS
|
incidence of hypoglycaemia (SMBG < 70 mg/dl), units: n° episodes/week
|
2 YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Emanuela Orsi, FOndazione IRCCS Ca' Granda Opedale Maggiore Policlinico Milano
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
March 3, 2017
First Submitted That Met QC Criteria
May 31, 2018
First Posted (Actual)
June 13, 2018
Study Record Updates
Last Update Posted (Actual)
June 13, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM1cc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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