Clinical trial NCT03176056: The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
Official title: Low Carbohydrate Diet for Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Low carbohydrate diet
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

Brief summary: This study determines whether an educational intervention with a 90 g/day LCD is safe, effective and has good compliance for poorly controlled type 2 diabetes patients.

Detailed description: Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧ 7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled 18-month trial at a medical center. Patients were randomly assigned to the interventional group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which maintained a standard calorie-restricted diet (CRD). All patients received periodic educational intervention and were monitored for weight, body composition, waist girth, hip girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol, Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media thickness (IMT),and medication effect score (MES).

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosis ≧ 1 year
* poorly controlled with HbA1c≧ 7.5% in the previous 3 months.
* aged 20 to 80
* without or with treatment \[ oral hypoglycemic agents (OHA) and/or insulin treatment)

Exclusion Criteria:

* pregnancy or lactating women
* impaired renal function with serum creatinine ≧ 1.5 mg/dl
* abnormal liver function \[alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis
* significant heart diseases (unstable angina, unstable heart failure)
* frequent gout attacks (≧ 3 times/year)
* participation in other weight loss programs or the use of weight-reducing drugs
* eating disorders
* could not complete the questionnaire
* poor compliance to protocol.

Primary outcomes:
measure: The improvement of glycemic control status
timeFrame: measured at baseline and every 3 months for 18 months after intervention
measure: The reduction of medication effect score (MES)
timeFrame: measured at baseline and every 3 months for 18 months after intervention
Secondary outcomes:
measure: The improvement of lipid profile
timeFrame: measured at baseline and every 3 months for 18 months after intervention
measure: The improvement of small dense low density lipoprotein (sdLDL)
timeFrame: measured at baseline and every 6 months for 18 months after intervention
measure: The maintenance of renal function
timeFrame: measured at baseline and every 3 months for 18 months after intervention
measure: The improvement of microalbuminuria.
timeFrame: measured at baseline and 18 month after intervention
measure: The improvement of carotid intima-media thickness (IMT)
timeFrame: measured at baseline and 18 month after intervention
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital and National Taiwan University
name: Chin-Ying Chen, MD, MHSc
role: STUDY_CHAIR
References: