Detemir Energy Expenditure Study

University of Surrey30 enrolled

Overview

This is a study designed to compare the effects of 2 long-acting insulins, detemir and insulatard, on energy expenditure,weight, fat composition, gut hormone profiles, glycaemic control and fat and muscle gene expression over a 6 month period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Obesity

Interventions

InsulatardDRUG

Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.

DetemirDRUG

Detemir insulin used as long-acting insulin in treatment phase of study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Type 2 diabetes 2. Treated with metformin 3. Already on treatment with a long-acting or intermediate insulin. 4. Over 18 years of age, 5. HbA1c \> 7.0% 6. BMI 27-40 7. Able and willing to perform self-blood glucose monitoring. 8. Able and willing to maintain consistent eating habits throughout the entire trial period. 9. Able and willing to maintain consistent physical activity level during the entire trial period Exclusion Criteria: 1. Patients on sulphonylureas or thiazolidinediones 2. Proliferative retinopathy that has required acute treatment within the last six months. 3. Impaired hepatic or renal functions. 4. Cardiac problems. 5. Uncontrolled hypertension (treated or untreated). 6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.

Locations (1)

Cedar Centre, Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

Outcomes

Primary Outcomes

Weight change

Time frame: 6 months

Secondary Outcomes

Energy Expenditure

Time frame: 6 months

Fat composition

Time frame: 6 months

Fat & muscle gene expression

Time frame: 6 months

Glycaemic control

Time frame: 6 months

Data from ClinicalTrials.gov

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