N/A
N=198
Lifestyle Intervention for Pakistani Women in Oslo
Metabolic Syndrome · Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00425269 ↗Enrolled (actual)
198
Serious AEs
—
Results posted
Jul 2014
Primary outcome: Primary: The Fasting Plasma Glucose Value, Baseline — 5.55; 5.53 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- lifestyle intervention (diet and physical activity) (Behavioral)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- University of Oslo
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Fasting Plasma Glucose Value, Baseline |
5.55; 5.53 | — |
| PRIMARY Plasma Glucose 2 h After Oral Glucose Tolerance Test, Baseline |
8.52; 8.41 | — |
| PRIMARY The Fasting Plasma Glucose, Post-test |
5.39; 5.66 | — |
| PRIMARY Plasma Glucose, 2-h, Post-test |
8.00; 8.20 | — |
| SECONDARY HbA1c, Baseline |
5.4; 5.4 | — |
| SECONDARY C-peptide, 0-h, Baseline |
855.0; 839.9 | — |
| SECONDARY C-peptid, 2-h, Baseline |
3851.5; 3628.9 | — |
| SECONDARY Insulin, 0-h, Baseline |
127.6; 116.3 | — |
| SECONDARY Insulin, 2-h, Baseline |
931.1; 839.5 | — |
| SECONDARY High-Density Lipoprotein Cholesterol, Baseline |
1.26; 1.25 | — |
| SECONDARY Triglycerides, Baseline |
1.4; 1.4 | — |
| SECONDARY Systolic Blood Pressure, Baseline |
115.6; 118.7 | — |
| SECONDARY Diastolic Blood Pressure, Baseline |
80.0; 80.8 | — |
| SECONDARY Waist Circumference, Baseline |
95.3; 96.2 | — |
| SECONDARY Body Mass Index, Baseline |
29.39; 29.73 | — |
| SECONDARY Intake of Vegetables, Fruit and Fruit Juice, Baseline |
328.9; 306.3 | — |
| SECONDARY Intake of Soft Drinks With Added Sugar, Baseline |
5.0; 4.4 | — |
| SECONDARY Intake of Red Meat, Baseline |
2.1; 2.0 | — |
| SECONDARY Intake of Poultry, Baseline |
2.1; 2.1 | — |
| SECONDARY Intake of Fish, Baseline |
0.97; 0.77 | — |
| SECONDARY HbA1C, Post-test |
5.4; 5.5 | — |
| SECONDARY C-peptid, 0-h, Post-test |
878.5; 914.6 | — |
| SECONDARY C-peptid, 2-h, Post-test |
3618.1; 3439.9 | — |
| SECONDARY Insulin, 0-h, Post-test |
121.8; 123.3 | — |
| SECONDARY Insulin, 2-h, Post-test |
861.8; 786.1 | — |
| SECONDARY High-Density Lipoprotein Cholesterol, Post-test |
1.24; 1.20 | — |
| SECONDARY Triglycerides, Post-test |
1.3; 1.5 | — |
| SECONDARY Systolic Blood Pressure, Post-test |
114.4; 117.1 | — |
| SECONDARY Diastolic Blood Pressure, Post-test |
78.6; 80.1 | — |
| SECONDARY Waist Circumference |
95.1; 96.8 | — |
| SECONDARY Body Mass Index, Post-test |
29.11; 29.65 | — |
| SECONDARY Intake of Vegetables, Fruit and Fruit Juice, Post-test |
375.4; 328.3 | — |
| SECONDARY Intake of Soft Drinks With Added Sugar, Post-test |
2.5; 5.1 | — |
| SECONDARY Intake of Red Meat, Post-test |
1.6; 2.0 | — |
| SECONDARY Intake of Poultry, Post-test |
1.9; 1.8 | — |
| SECONDARY Intake of Fish, Post Test |
1.13; 1.11 | — |
Summary
Immigrants from South Asia in Norway have a high prevalence of type 2 diabetes and conditions related to the metabolic syndrome. It has been documented that these conditions may be prevented by changes in lifestyle. No previous intervention studies on immigrants with focus on diet and physical activity have been carried out in Norway. This project concerns a randomized controlled trial with intervention to change diet and physical activity in 200 high risk female Pakistani immigrants living in Oslo. The intervention will be evaluated both in terms of outcome and process.
Eligibility Criteria
Inclusion Criteria
- Risk score developed by Ramachandran et al for Asian Indians:
- BMI, waist circumference, family history of diabetes and sedentary physical activity
Exclusion Criteria
- Type 1 diabetes.
- Positive auto antibodies.
- Diagnosis of type 2 diabetes more than 6 months.
- Medication for type 2 diabetes.
- Pregnancy at intervention start.
- Suffering from heart attack or stroke the last 3 months.
- Already participating in organised physical exercise.
Data sourced from ClinicalTrials.gov (NCT00425269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.