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

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Metabolic Syndrome
• Interventions: Behavioral: Nutritional Counseling

• Registration Number: NCT02821585
• Lead Sponsor: Institut de Recherches Cliniques de Montreal

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Status Verified: 2017-09
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Fat Diet	Nutritional Counseling	Participants will receive nutritional lessons on the principles of the low fat diet. This type of diet is defined with a carbohydrate intake greater than 45% of total energy intake, 15-20% of proteins, less than 30% of lipids and less than 7% for saturated fat. Nine sessions with a nutritionist are planned to cover various topics of the diet.
Mediterranean Diet	Nutritional Counseling	Participants will receive nutritional lessons on the principles of the Mediterranean diet. This type of diet is defined with a carbohydrate intake of 45-55% of total energy intake, 15-20% of proteins, 30-35% of lipids and less than 7% for saturated fat. Nine sessions with a nutritionist are planned to cover various topics of the diet.

Primary Outcome Measures

Name	Time	Method
Change in Waist Circumference	Change from baseline and 6 months measure of 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).

Secondary Outcome Measures

Name	Time	Method
Percentage of body fat	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)	The outcome will be measured using a DEXA-scan
Insulin Sensitivity	The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)	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.
Lipid profile	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)	A blood test will measure level of total cholesterol, triglycerides and LDL cholesterol.
Glycemic variability	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)	Glycated hemoglobin will be measured with a blood sample. Hypoglycemia frequency will be measured with a 4-day glycemia journal.
Systolic and diastolic Blood pressure	The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)	Average of 3 measures (systolic, diastolic and pulse) after a 5 minutes resting period
Body Mass Index (BMI)	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.	Weight (kg) / (height (m) x height (m))
Mediterranean Diet Score	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).	The questionnaire allows the calculation of a score reflecting the adherence to the mediterranean diet.

Trial Locations

Locations (1)

Institut de recherches cliniques de Montréal; 🇨🇦 Montréal, Quebec, Canada