Diabetes Intervention Accentuating Diet and Enhancing Metabolism
Nyckelord
Abstrakt
Beskrivning
The aim of the proposed study is to conduct a pragmatic randomised controlled clinical trial randomising young adult patients with obesity and type 2 diabetes to an intervention incorporating a low calorie diet and physical activity or usual care. The investigators hypothesise that patients in the low calorie intervention arm will have greater weight reduction leading to significant improvement in glycaemic control and cardiovascular risk. The primary outcome will be weight loss. The low calorie diet intervention arm is designed to achieve and maintain significant weight loss through decreased calorie intake, increased physical activity, and behaviour change. Usual care will include routine advice about diet and physical activity. Secondary outcomes include diabetes control, body composition, and quality of life.
Datum
| Senast verifierad: | 05/31/2020 |
| Först skickat: | 06/11/2017 |
| Beräknad anmälan inlämnad: | 07/19/2017 |
| Först publicerad: | 07/20/2017 |
| Senaste uppdatering skickad: | 07/22/2020 |
| Senaste uppdatering publicerad: | 07/26/2020 |
| Faktiskt startdatum för studien: | 07/15/2017 |
| Uppskattat primärt slutdatum: | 02/18/2020 |
| Beräknat slutfört datum: | 02/17/2021 |
Tillstånd eller sjukdom
Intervention / behandling
Dietary Supplement: Lifestyle Intervention
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| Experimental: Lifestyle Intervention The intervention includes the use of Low Energy Diet replacement products in combination with physical activity, followed by gradual introduction of food, and increasing physical activity. Behavioural support for the lifestyle intervention will also be provided. | Dietary Supplement: Lifestyle Intervention Low Energy Diet |
| No Intervention: Usual Care This will be based on current clinical practice aiming to reduce diabetes symptoms and complications, and general recommendations on diet and physical activity. |
Urvalskriterier
| Åldrar berättigade till studier | 18 Years Till 18 Years |
| Kön som är berättigade till studier | All |
| Accepterar friska volontärer | Ja |
| Kriterier | Inclusion Criteria: - Type 2 diabetes mellitus (based on ADA diagnostic criteria) ; - Diabetes of ≤ 3-year duration; - BMI >27.0 kg/m² (based on WHO cut-points for ethnicity 119); - Men and women; - Age 18-50 years; - Originating from the Middle East and North Africa region and resident in Qatar; - Able to commit to the study duration; - Able to give informed consent and willing to participate in the study. Exclusion Criteria: - Type 1 diabetes mellitus based on clinical history; - Cardiovascular event in the previous 6 months; - Chronic kidney disease stage 3b or greater (eGFR <30 mL/min/1.73m²); - Currently pregnant, lactating, or planning pregnancy within the study period; - Any condition precipitating fluid overload such as heart failure (NYHA class > I) and liver cirrhosis; - Significant previously diagnosed psychiatric disorder (e.g. schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder); - Uncontrolled depression (based on hospital anxiety and depression scale); - Uncontrolled epilepsy; - Known lactose intolerance; - Severe arthritis preventing walking; - Active gout; - Active gallstone disease or known asymptomatic gallstones. |
Resultat
Primära resultatåtgärder
1. Weight loss [12 months]
Sekundära resultatåtgärder
1. Glycaemic control [12 months]
2. Patient reported outcomes [12 months]
Andra resultatåtgärder
1. Insulin sensitivity/resistance [12 months]
2. Body Mass Index [12 months]
3. Waist Circumference [12 months]
