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Completed

NCT Number: NCT03165877

Effect of Low-glycemic Index Meals Intake on DM2 Women Under Metformin Therapy

To compare the effect of low-glycemic index versus control lunches and dinners intake on indicators of satiety, metabolic parameters and liver steatosis degree on women with type 2 diabetes under metformin therapy.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjets with type 2 diabetes mellitus diagnosis under metformin therapy.
  • Female sex.
  • Aged 30 to 65 years.
  • Body Mass Index (BMI) 22 to 34.9 kg / m2.

Exclusion criteria

  • Women with insulin-releasing drugs or insulin treatment.
  • Patients with diabetic nephropathy, retinopathy, chronic kidney disease, stroke.
  • Subjects with hypothyroidism without treatment.
  • Individuals with food allergies or intolerances.
  • Women who present an intake of ≥20 g of alcohol per day quantified through a closed consumption frequency survey.
  • Patients with previously diagnosed hepatitis, hepatic cirrhosis or liver cancer.

Treatment and study plan

Low-glycemic index

Other

Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.

Control

Other

Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.

Primary outcomes

  1. Change from Baseline Fasting glycemia at 12 weeks

    Time frame: up to 12 weeks

    Fasting glycemia (mg/dL) was measured at Baseline and at 12 weeks

  2. Postprandial glycemia

    Time frame: up to 12 weeks

    Postprandial glycemia (mg/dL) was measured for lunch and dinner of one day at 4, 8 and 12 weeks

  3. Change from Baseline Glycosylated hemoglobin at 12 weeks

    Time frame: up to 12 weeks

    Glycosylated hemoglobin was measured at Baseline and at 12 weeks

  4. Change from Baseline Triglycerides at 12 weeks

    Time frame: up to 12 weeks

    Triglycerides (mg/dL) was measured at Baseline and at 12 weeks

  5. Change from Baseline Total cholesterol/HDL ratio at 12 weeks

    Time frame: up to 12 weeks

    Total cholesterol/HDL ratio was measured at Baseline and at 12 weeks

  6. Change from Baseline HDL cholesterol at 12 weeks

    Time frame: up to 12 weeks

    HDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks

  7. Change from Baseline Total cholesterol at 12 weeks

    Time frame: up to 12 weeks

    Total cholesterol (mg/dL) was measured at Baseline and at 12 weeks

  8. Change from Baseline LDL cholesterol at 12 weeks

    Time frame: up to 12 weeks

    LDL cholesterol (mg/dL) was measured at Baseline and at 12 weeks

  9. Change from Baseline High-sensitivity C-reactive protein (hs-CRP) at 12 weeks

    Time frame: up to 12 weeks

    High-sensitivity C-reactive protein (mg/L) was measured at Baseline and at 12 weeks

  10. Change from Baseline Aspartate aminotransferase (AST) at 12 weeks

    Time frame: up to 12 weeks

    Aspartate aminotransferase (UI/L) was measured at Baseline and at 12 weeks

  11. Change from Baseline Alanine aminotransferase (ALT) at 12 weeks

    Time frame: up to 12 weeks

    Alanine aminotransferase (UI/L) was measured at Baseline and at 12 weeks

  12. Change from Baseline Liver steatosis degree at 12 weeks

    Time frame: up to 12 weeks

    Liver steatosis degree was measured at Baseline, 4, 8 and 12 weeks

  13. Subjective satiety

    Time frame: 7 days

    Visual Analog Scale (VAS) was applied after lunches and dinners of 7 days to each subject

  14. Objective satiety

    Time frame: 7 days

    24-hour recall was applied the same 7 days as the VAS to each subject

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: up to 12 weeks

    Body mass index (BMI) (kg/m2) was measured at Baseline, 4, 8 and 12 weeks.

  2. Waist circumference

    Time frame: up to 12 weeks

    Waist circumference (cm) was measured at Baseline, 4, 8 and 12 weeks.

  3. Alcohol intake

    Time frame: up to 12 weeks

    Alcohol intake (g/day) was measured at Baseline, 4, 8 and 12 weeks.

  4. Physical activity

    Time frame: up to 12 weeks

    Physical activity was measured at Baseline, 4, 8 and 12 weeks.

  5. Adherence to treatment

    Time frame: up to 12 weeks

    The percentage of adherence to treatment was measured through a daily survey for 12 weeks. It is the calculation of compliance with planned meals intake (number of lunches and dinners eaten / total number of lunches and dinners of the study x 100).

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Registry information

Official study title

Effect of Low-glycemic Index Lunches and Dinners Intake on Indicators of Satiety, Metabolic Parameters and Liver Steatosis Degree on Women With Type 2 Diabetes Under Metformin Therapy: Controlled Clinical Trial

Acronym: LGIM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 24, 2017
Registry last updated
May 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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