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

NCT02821585 | Completed

• 1 other identifier: MEDIT-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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).

• 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.

• Percentage of body fat

  The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)

• Insulin Sensitivity

  The outcome will be calculated at admission, visit 7 (3 months) and visit 10 (6 months)

• Systolic and diastolic Blood pressure

  The outcome will be measured at admission, visit 7 (3 months) and visit 10 (6 months)

Study Arms (2)

Mediterranean Diet

ACTIVE COMPARATOR

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.

Behavioral: Nutritional Counseling

Low Fat Diet

PLACEBO COMPARATOR

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.

Behavioral: Nutritional Counseling

Interventions

Nutritional Counseling BEHAVIORAL

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.

Low Fat Diet; Mediterranean Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Waist circumference \>102cm ♂ or \>88cm ♀
• Triglycerides \>1.7mmol/L or medication
• Cholesterol-HDL \<1.0mmol/L ♂ or \<1.3mmol/L ♀ or medication
• Blood pressure ≥130/85 mmHg or medication
• Estimated insulin resistance (eGDR \<6.29)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

Related Publications (1)

• Fortin A, Rabasa-Lhoret R, Lemieux S, Labonte ME, Gingras V. Comparison of a Mediterranean to a low-fat diet intervention in adults with type 1 diabetes and metabolic syndrome: A 6-month randomized trial. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1275-1284. doi: 10.1016/j.numecd.2018.08.005. Epub 2018 Aug 30.

  PMID: 30459054 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Metabolic Syndrome

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Remi Rabasa-Lhoret

  IRCM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 1, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2017-09

Locations

CA (1)