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

NCT ID: NCT02821585

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet

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.

Group Type: ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Nutritional Counseling

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Remi Rabasa-Lhoret

Role: STUDY_DIRECTOR

IRCM

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30459054 (View on PubMed)

Other Identifiers

MEDIT-1

Identifier Type: -

Identifier Source: org_study_id