Early management of type 2 diabetes: the way to regression or remission

Early management of type 2 diabetes: the way to regression or remission - a 3-year, prospective, randomised, clinic-based, interventional study with parallel groups

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81672669

Enrollment

250

Registered

2009-05-29

Start date

2006-01-01

Completion date

Unknown

Last updated

2019-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Eligible newly diagnosed type 2 diabetes mellitus patients were randomised (2:1) to receive either a lifestyle intervention and SMBG as an educational tool and in order to apply step-by-step pharmacol

these abilities were revised each visit. A 6-point profile, before and 2-hours after breakfast, lunch and dinner, every 3 days was recommended at baseline and after any pharmacological change. If fast

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed type 2 diabetes after two fasting glucose plasma values greater than 125 mg/dl between January 2006 and December 2007 2. Aged between 18 and 80 years, either sex 3. Less than 6 months of duration from the first fasting plasma glucose value less than 126 mg/dl 4. Absence of ketones in two first morning urine samples

Exclusion criteria

Exclusion criteria: 1. More than 6 months of the first fasting glucose level greater than 125 mg/dl 2. Ketones positives in urine samples 3. Unable to perform SMBG 4. Presence of a severe disease

Design outcomes

Primary

Measure	Time frame
To estimate the remission and regression rate of type 2 diabetes mellitus: 1. Regression is considered yearly and established when patients achieved HbA1c less than 6% on metformin treatment and have normal levels of: 1.1. Fasting plasma insulin (9 - 26) 1.2. HOMA (1 - 3) 1.3. FPG less than 100 mg/dl 2. Remission is considered yearly and established when patients achieved HbA1c less than 6.5% with metformin and other pharmacological treatment	—

Measure

Time frame

To estimate the remission and regression rate of type 2 diabetes mellitus: 1. Regression is considered yearly and established when patients achieved HbA1c less than 6% on metformin treatment and have normal levels of: 1.1. Fasting plasma insulin (9 - 26) 1.2. HOMA (1 - 3) 1.3. FPG less than 100 mg/dl 2. Remission is considered yearly and established when patients achieved HbA1c less than 6.5% with metformin and other pharmacological treatment

—

Secondary

Measure	Time frame
Estimate changes in: 1. HbA1c 2. Insulin 3. HOMA 4. Total (HDL and LDL) cholesterol 5. Triglycerides 6. Apolipoprotein B 7. Cytokines 8. Body weight 9. Waist circumference 10. Blood pressure An intermediate analysis after the first year of follow-up was performed to assess the adherence to changes in lifestyle.	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026