|- candidate number||9146|
|- NTR Number||NTR2773|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-feb-2011|
|- Secondary IDs||10/095 METC AMC|
|- Public Title||Breakfast replacement by a low-glycemic index liquid formula in patients with diabetes mellitus type 2.|
|- Scientific Title||Breakfast replacement by a low-glycemic index liquid formula in patients with diabetes mellitus type 2.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II), Breakfast, Glycemic index|
|- Inclusion criteria||1. DM2;|
2. Age 30-75y;
3. Body mass index 25-40 kg/m2.
|- Exclusion criteria||1. Use of any other anti-diabetic drug than metformin;|
2. Acute or chronic metabolic disease (other than diabetes) that will impair metabolism or digestion and absorption of food, including gastrointestinal, hepatic or renal disease;
3. Regular breakfast skipping;
4. Inability to give written informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||24-feb-2011|
|- planned closingdate||1-dec-2012|
|- Target number of participants||20|
|- Interventions||Isoenergetic replacement of regular whole-food breakfast by Glucerna SR drinkvoeding (Abbott Laboratories B.V., Zwolle, Netherlands) will be compared to regular whole-food breakfast. Both will be given during 12 weeks. |
|- Primary outcome||Fasting and postprandial glucose and insulin concentrations.|
|- Secondary outcome||1. Body weight;|
3. Glucose tolerance (determined by an oral glucose tolerance test);
4. Plasma lipid concentrations;
5. Oxidative stress.
|- Timepoints||Every 6 weeks: Fasting glucose, insulin, HbA1c and lipid concentrations, oxidative stress, body weight, continuous glucose monitoring;|
Every 12 weeks: Postprandial glucose and insulin concentrations and oral glucose tolerance test.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.H.L.T. Bisschop|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.H.L.T. Bisschop|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||Stenvers DJ, Schouten LJ, Jurgens J, Endert E, Kalsbeek A, Fliers E, Bisschop PH. Breakfast replacement with a low-glycaemic response liquid formula in
patients with type 2 diabetes: a randomised clinical trial. British Journal of Nutrition (2014), 112, 504–512|
|- Brief summary||Rationale: |
Postprandial glucose excursions in diabetes mellitus are an important determinant of glycemic control. Postprandial glucose concentrations are determined by the amount and rate of carbohydrate absorption from the intestine, the prevailing insulin concentration and the potency of insulin to lower plasma glucose (insulin sensitivity). Consequently, food with lower postprandial glucose excursions (low-glycemic index food) may have a favourable effect in patients with diabetes mellitus.
To determine the effect of breakfast replacement by a low-glycemic index (GI) liquid meal on postprandial glucose and insulin excursions, HbA1c, body weight and lipid profile in patients with diabetes mellitus type 2.
Cross-over open-label intervention study.
Patients with diabetes mellitus type 2, age 30-75y, body mass index 25-40 kg/m2.
Isoenergetic breakfast replacement by a low-GI liquid meal.
Main study parameters/endpoints:
24-hour glucose profile, body weight, HbA1c, insulin sensitivity, lipid profile.
|- Main changes (audit trail)||23-Jul-2012: The number of participants has been adjusted from 50 to 20. A new poweranalysis has indicated this - NM|
|- RECORD||21-feb-2011 - 3-sep-2014|