on-prescriptive low-carbohydrate nutritional approach in the remission of prediabetes (pDM2) and Type 2 Diabetes Mellitus (DM2)

Not Applicable

• Conditions: Pre-Diabetes; Type 2 Diabetes

• Registration Number: RBR-22mdrvy
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-21
• Last Update Posted: 23 January 2024
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Have a Diagnosis of Pre-Diabetes: Fasting blood glucose equal to or greater than 100 mg/dL and less than 125 mg/dL; Glycated Hemoglobin (HbA1c) equal to or greater than 5.7% and less than 6.5%; Blood glucose 2 hours after Oral Glucose Tolerance Test equal to or greater than 140 mg/dL and equal to or less than 199 mg/dL. Or have a diagnosis of type 2 Diabetes Mellitus: Fasting blood glucose equal to or greater than 125 mg/dL; Glycated Hemoglobin (HbA1c) equal to or greater than 6.5%; Blood glucose 2 hours after Oral Glucose Tolerance Test greater than 199 mg/dL. Participants may or may not be using oral anti-diabetic or antihypertensive medications. They must have a cell phone compatible with the WhatsApp® messaging application and be able to communicate by sending photos and texts. Be over 18 years old. Both genders. Agree with the protocol for treatment. Live in Belo Horizonte – MG. Sign authorization to participate in the research through the Free and Informed Consent Form (TCLE). Have a glucometer and agree to measure blood glucose 6x a day (1x a week for Diabetics and 1x a month for pre-diabetics)

Exclusion Criteria

Patients who have proliferative diabetic retinopathy (can enter the study only after laser photocoagulation therapy). Present reports, suspicion or diagnosis of gastroparesis. Have eating disorders (binge eating, anorexia, etc.). Being an athlete (more than 2 hours of exercise per day). Have a creatinine clearance <60. Have albumin excretion above 300 mg/day (macroalbuminuria). Pregnant women. Nursing mothers. C-peptide below the reference value (<0.6 ng/mL). Users of synthetic insulin. Vegans, vegetarians, frugivores

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The result of the study is expected to be remission of pre-diabetes and/or type 2 diabetes, with an improvement in blood glucose parameters (below 100mg/dL) and glycated hemoglobin (below 5.7%).

Secondary Outcome Measures

Name	Time	Method
Improvement in the participants' lipid and inflammatory profile is expected, such as: increase in HDL cholesterol (>50 mg/dL for women and >40 mg/dL for men), improvement in the relationship between LDL cholesterol of the ApoA1 type and cholesterol ApoB type LDL (<60 for women and <70 for men), decreased triglycerides (<150 mg/dL), decreased basal insulin (< 20 µU/mL), decreased fribrinogen (200 to 400 mg/dL), decreased ferritin (women from 24 to 307 ng/mL and men from 24 to 336 ng/mL), decreased homocysteine (5 to 15 µmol/L) and decreased uric acid (3.0 to 7.0 mg/ dL)