Zinc supplementation and exercise to improve therapy for type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Type 2 diabetes mellitus

• Registration Number: ISRCTN64095258
• Lead Sponsor: niversity of Chile, Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-21
• Study Completion: 2020-03-31
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Aged 35-69 years
2. Type 2 diabetes
3. Diagnosed with type 2 diabetes for less than 15 years
4. Sedentary, defined as less than 3 sessions per week of 30 minutes of physical activity and/or sport
5. BMI 20-40 kg/m² for at least 3 months prior to screening
6. Stable body weight (variation <5%) for at least 3 months prior to screening
7. Glycated haemoglobin (HbA1c) 6.5-9.0% and/or fasting glycemia <180 mg/dL

Exclusion Criteria

1. Insulin therapy
2. History of ketoacidosis or hyperosmolar hyperglycemic non-ketotic syndrome in the previous 6 months
3. Estimated glomerular filtration rate (eGFR) <60 mL/min by the MDRD equation
4. Alanine aminotransferase or aspartate aminotransferase >2.5 times the upper normal limit
5. Congestive heart failure (grade III-IV according to the New York Heart Association Criteria 1994)
6. Uncontrolled hypertension
7. Diabetic polyneuropathy, peripheral macrovascular pathology or diabetic foot
8. Proliferative diabetic retinopathy or severe nonproliferative diabetic retinopathy
9. History of stroke, transient ischemic attack or acute myocardial infarction in the previous 5 years
10. Recent surgery or acute infection in the previous 3 months
11. Major psychiatric disorder affecting compliance
12. Use of antipsychotic medications
13. Use of anticoagulant medications
14. Uncontrolled thyroid disorders
15. Systemic use of glucocorticoid steroids within previous 6 weeks
16. Osteoarticular or neurologic conditions able to limit physical activity
17. Cancer diagnosis or treatment in the past 5 years, with the exception of cancers that have been cured, and carry a good prognosis
18. Regular alcohol intake >2 portions per day
19. HIV positive
20. Pregnant or lactating women
21. Taken vitamin-mineral supplements during the previous 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> An intravenous glucose tolerance test after an overnight fast will be complete, with blood samples drawn 15 and 5 minutes before a glucose bolus (0.3 g/kg body weight as 50% glucose in saline solution) administered over 2 minutes. Samples will then be drawn at 2, 3, 4, 5, 6, 8, 10, 12, 14, 19, 22, 24, 27, 30, 40, 50, 70, 90, 120, 150, and 180 min after the bolus. Insulin (0.05 U/kg body weight) will be infused over 5 minutes, beginning 20 minutes after the glucose bolus. The data will be analysed using the MINMOD program for the following insulin sensitivity indices:<br> 1. Insulin sensitivity (Si)<br> 2. Acute insulin response to glucose (AINg)<br> 3. Glucose effectiveness (Sg)<br> 4. Fractional metabolic clearance rate of insulin (kI)<br> 5. Disposition index (DI)<br> This procedure will be carried out at the baseline and after 24 weeks.<br>