Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MEDIT  

Official title:

Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821585
• Other study ID #: MEDIT-1
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 2018

Study information

• Verified date: September 2017
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin resistance) that increase the cardiovascular risk. The investigators have observed in previous studies a strong association between the adherence to a Mediterranean diet and the prevalence of metabolic syndrome on patients with metabolic syndrome. However, no intervention has been realized on this population and the current recommendations (low fat diet) differ from the Mediterranean diet. A nutritional intervention on the principles of the Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in Type 1 diabetes patients. The main objective of this study is to examine the impact of a nutritional intervention on the waist circumference after 6 months of an intervention group (Mediterranean diet) versus a control group (low fat diet).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 Diabetes for at least 12 months

• On intensive insulin therapy with multiple daily injections or on insulin pump

• Be overweight or obese (BMI=25 kg/m2)

• Stable weight for at least 3 months

• If on medication for thyroid, hypertension or dislipidemia: stable doses in the last 3 months

• Presenting at least 3 of the 5 following criteria for metabolic syndrome:

1. Waist circumference >102cm ? or >88cm ?

2. Triglycerides >1.7mmol/L or medication

3. Cholesterol-HDL <1.0mmol/L ? or <1.3mmol/L ? or medication

4. Blood pressure =130/85 mmHg or medication

5. Estimated insulin resistance (eGDR <6.29)

Exclusion Criteria:

• Mental incapacity, refusal or linguistic barrier that could affect comprehension or cooperation with the study

• Ongoing pregnancy

• Diet corresponding to the criteria of a mediterranean diet (score=27)

• Vegetarianism

• Major diabetes complications

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome
• Type 1 Diabetes

Intervention

Behavioral:
• Nutritional Counseling
Carbohydrate counting will be reviewed, as well as hypoglycemia management. The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Waist Circumference	The outcome will be measured every month, at admission and visits 4 (1 month) - 6 (2 months) -7 (3 months) -8 (4 months) -9 (5 months) -10 (6 months) -11 (9 months).	Change from baseline and 6 months measure of waist circumference
Secondary	Mediterranean Diet Score	The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.	The outcome will be measured based on an internet food frequency questionnaire filled by patients at admission, visit 7 (3 months) and visit 10 (6 months).
Secondary	Body Mass Index (BMI)	Weight (kg) / (height (m) x height (m))	Weight wil be measured every month: at admission and visit 4 (1 month), 6 (2 months), 7 (3 months), 8 (4 months), 9 (5 months) and 10 (6 months). The height will be measured only at admission.
Secondary	Percentage of body fat	The outcome will be measured using a DEXA-scan	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Secondary	Insulin Sensitivity	The outcome will be estimated based on a formula validated for type 1 diabetes subjects. The formula takes into account waist/hip ratio, glycated hemoglobin and hypertension.	The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)
Secondary	Systolic and diastolic Blood pressure	Average of 3 measures (systolic, diastolic and pulse) after a 5 minutes resting period	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Secondary	Lipid profile	A blood test will measure level of total cholesterol, triglycerides and LDL cholesterol.	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)
Secondary	Glycemic variability	Glycated hemoglobin will be measured with a blood sample. Hypoglycemia frequency will be measured with a 4-day glycemia journal.	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)